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Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02772783
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Belinda Lennerz, Boston Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Other: high GI meal
Other: low GI meal
Drug: euglycemic insulin clamp
Drug: primed-variable insulin infusion
Enrollment 15
Recruitment Details Participants were recruited from the Boston Children's Hospital Diabetes Program and via postings in the surrounding medical area.
Pre-assignment Details

Participants underwent a 5 hour pre-randomization visit to establish IV insulin requirement for a low GI test meal. Participants were positioned in the MRI scanner for a brief test sequence.

Participants were excluded if they were unable to finish these pre-randomization procedures, or if they decided to not continue.

Arm/Group Title High GI Matched Glucose - Low GI - High GI Matched Insulin High GI Matched Insulin - Low GI - High GI Matched Glucose
Hide Arm/Group Description

In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage in the following order:

  1. High GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.

    - 1-week wash-out

  2. Low GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia (comparison condition B); 1 day.

    - 1-week wash-out

  3. High GI meal with IV insulin matching the low GI meal, resulting in hyperglycemia (experimental condition C); 1 day.

High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.

Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration.

In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage in the following order:

  1. High GI meal with IV insulin matching the low GI meal (as determined during the pre-randomization visit), resulting in hyperglycemia (experimental condition C); 1 day.

    - 1-week wash-out

  2. Low GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia (comparison condition B); 1 day.

    - 1-week wash-out

  3. High GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.

High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.

Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration.

Period Title: Experimental Condition 1, 1 Day
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Wash-out, 1 Week
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Comparison Condition, 1 Day
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Wash-out, 1 Week
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Experimental Condition 2, 1 Day
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage:

  • High GI meal covered with IV insulin to to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.
  • 1-week wash-out
  • Low GI meal covered with IV insulin to achieve euglycemia (comparison condition B); 1 day.
  • 1-week wash-out
  • High GI meal with IV insulin matching the low GI meal, resulting in hyperglycemia (experimental condition A); 1 day.

The order of experimental conditions A and B was randomized.

High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.

Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration.

Because all participants completed all interventions, results are presented in aggregate for the entire study group.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
21  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants
21  (1.4)
1.Primary Outcome
Title Nucleus Accumbens Blood Flow
Hide Description Cerebral blood flow in the right and left nucleus accumbent was measured by arterial spin labeling (MRI). Blood flow was normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan.
Time Frame 4 hrs postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 15 15 15
Least Squares Mean (Standard Error)
Unit of Measure: ml/g/min per ml/g/min
right 1.13  (0.02) 1.16  (0.02) 1.15  (0.02)
left 1.21  (0.02) 1.18  (0.02) 1.18  (0.02)
2.Secondary Outcome
Title Nucleus Accumbens Blood Flow
Hide Description Cerebral blood flow in the right and left nucleus accumbent was measured by arterial spin labeling (MRI). Blood flow was normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan.
Time Frame 1 hr postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 15 15 15
Least Squares Mean (Standard Error)
Unit of Measure: ml/g/min per ml/g/min
right 1.12  (0.02) 1.16  (0.02) 1.11  (0.02)
left 1.20  (0.02) 1.19  (0.02) 1.14  (0.02)
3.Secondary Outcome
Title Blood Flow in Other Brain Areas Involved in Intake Regulation - Dorsal Caudate
Hide Description Cerebral blood flow was measured by arterial spin labeling (MRI). Grouped MRI data was visually inspected for postprandial differences between conditions. Blood flow from a cluster contracting the conditions in the right dorsal caudate, just lateral to the nucleus accumbent, was extracted, normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan.
Time Frame 4 hrs postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 15 15 15
Least Squares Mean (Standard Error)
Unit of Measure: ml/g/min per ml/g/min
0.60  (0.01) 0.59  (0.01) 0.64  (0.01)
4.Secondary Outcome
Title Blood Flow in Other Brain Areas Involved in Intake Regulation - Ventrolateral Striatum
Hide Description Cerebral blood flow was measured by arterial spin labeling (MRI). Grouped MRI data was visually inspected for postprandial differences between conditions. Blood flow from a cluster contracting the conditions in the right ventrolateral striatum, just lateral to the nucleus accumbent, was extracted, normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan.
Time Frame 1 hr postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 15 15 15
Least Squares Mean (Standard Error)
Unit of Measure: ml/g/min per ml/g/min
0.60  (0.01) 0.61  (0.01) 0.60  (0.01)
5.Secondary Outcome
Title Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation
Hide Description Cerebral blood oxygen concentration level was measured by resting state functional MRI (rs-fMRI). Seed based analysis was performed with the seed on the right Nucleus Accumbens. Functional connectivity between Nucleus Accumbens and Hypothalamus was assessed through extraction of temporal correlation measures.
Time Frame 4 hrs postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 13 13 13
Least Squares Mean (Standard Error)
Unit of Measure: unite-less correlation
0.26  (0.08) 0.24  (0.08) 0.25  (0.08)
6.Secondary Outcome
Title Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation
Hide Description Cerebral blood oxygen concentration level was measured by resting state functional MRI (rs-fMRI). Seed based analysis was performed with the seed on the right Nucleus Accumbens. Functional connectivity between Nucleus Accumbens and Hypothalamus was assessed through extraction of temporal correlation measures. Functional connectivity between Nucleus Accumbens and other brain areas was visually assessed.
Time Frame 1 hr postprandial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description:

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention.

Overall Number of Participants Analyzed 13 13 13
Least Squares Mean (Standard Error)
Unit of Measure: unite-less correlation
0.36  (0.09) 0.15  (0.09) 0.15  (0.09)
7.Other Pre-specified Outcome
Title Plasma Glucose Level
Hide Description blood samples will be obtained every 30 minutes
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Serum Insulin Level
Hide Description blood samples will be obtained every 30 minutes
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Serum Fatty Acids
Hide Description blood samples will be obtained every 30 minutes
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Plasma Ghrelin
Hide Description blood samples will be obtained every 30 minutes and analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Plasma GLP-1
Hide Description blood samples will be obtained every 30 minutes and analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Plasma PYY
Hide Description blood samples will be obtained every 30 minutes and analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Plasma CCK
Hide Description analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Plasma Glucagon
Hide Description blood samples will be obtained every 30 minutes and analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Plasma Leptin
Hide Description analyzed as part of a metabolic hormone panel
Time Frame 0-4.5 hrs postprandial
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Metabolomics
Hide Description LC-MS/MS methodology using several chromatographic stationary phases for > 400 metabolites
Time Frame 0, 1 and 4 hrs postprandial
Outcome Measure Data Not Reported
Time Frame Enrollment through study completion (on average 2 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Hide Arm/Group Description

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.

After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.

Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.

All-Cause Mortality
High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High GI With Matched to Low GI Glucose (HGI HI) Low GI (LGI) High GI With Matched to Low GI Insulin (HGI LI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)      1/15 (6.67%)    
Cardiac disorders       
Tachycardia *  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
dizzyness   1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Belinda Lennerz
Organization: Boston Children's Hospital
Phone: 617 355 7476
EMail: belinda.lennerz@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Belinda Lennerz, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02772783    
Other Study ID Numbers: IRB-P00022176
IRB- 2016P000079 ( Other Identifier: Beth Israel Deaconess Medical Center )
First Submitted: May 11, 2016
First Posted: May 16, 2016
Results First Submitted: February 17, 2020
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021