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Trial record 28 of 7493 for:    Area Under Curve

Evaluation of Fats on Postprandial Glucose Control (Nabucco)

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ClinicalTrials.gov Identifier: NCT01869790
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
Joslin Diabetes Center

Brief Summary:

The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes.

Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals.

The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat.

The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Different fat types Not Applicable

Detailed Description:

Subjects for this study will be adults with type 1 diabetes who use insulin pump in their diabetes self-management. Prior to admission the the clinical research center the basal rates and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical procedures.

Subjects will be admitted to the clinical research center in mid-morning following a light breakfast at home. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial glucose levels 3-6 hours after start of the meal will be higher following lunches B and D, compared to lunches A and C.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of "Fat" Bolus for Coverage of Higher Fat Meals.
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meal challenge
Different fat types
Other: Different fat types
Saturated, monounsaturated fats




Primary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: 0-180 minutes vs 180-360 minutes ]
    One-way repeated measures ANOVA will be used to analyze area under curve differences between the three lunches as well as time in target range (80-180 mg/dL), peak blood glucose, time to peak blood glucose, time to return to baseline blood glucose.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (aged 18-75 years) with type 1 diabetes > 3 years.
  • On insulin pump therapy.
  • A1c < 8.5%.

Exclusion Criteria:

  • History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.
  • Eating disorder.
  • Diet allergies.
  • Special diet restrictions, such as vegan or any nut allergy.
  • Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).
  • High-titre insulin autoantibodies with delayed insulin kinetics.
  • Women who are breast feeding, pregnant, or wanting to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869790


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Boston Children’s Hospital
Investigators
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Principal Investigator: Howard Wolpert, MD Joslin Diabetes Center

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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01869790     History of Changes
Other Study ID Numbers: Prandial bolus coverage
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases