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LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

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ClinicalTrials.gov Identifier: NCT00607867
Recruitment Status : Terminated (The funding ended before the study was completed.)
First Posted : February 6, 2008
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus
Diet
Interventions Other: LoBAG30 diet
Other: Control Diet
Enrollment 20
Recruitment Details  
Pre-assignment Details Proposed study design was 20 subjects, 10/arm. (Parallel arm design requested by grant Reviewers.) At the end of the funding period, 14 subjects had been enrolled and studied, 7 in each arm.
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title LoBAG30 Diet Control Diet Total
Hide Arm/Group Description A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat. A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
Subjects with type 2 diabetes being treated with metformin
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
62
(51 to 71)
61
(53 to 66)
61.6
(51 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
7
 100.0%
14
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Change in %Hemoglobin A1c at 5 Weeks From Baseline
Hide Description Hemoglobin A1c measured before and after 5 weeks on the diet
Time Frame Baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: Change in % A1c at 5 weeks from baseli
-0.9  (0.23) -0.9  (0.16)
2.Primary Outcome
Title Change in Total Glucose Area at 5 Weeks From Baseline
Hide Description The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.
Time Frame Baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: mg hr/dl
-957  (302) -691  (84)
3.Primary Outcome
Title Change in Body Weight at 5 Weeks From Baseline
Hide Description Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.
Time Frame baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: pounds
-0.7  (0.7) -2.6  (1.0)
4.Primary Outcome
Title Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline
Hide Description Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.
Time Frame baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: mg/dl
-22  (16.5) -33  (4.7)
5.Secondary Outcome
Title Microalbumin Excretion
Hide Description change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: mg/day
-0.9  (4.2) -8.3  (3.5)
6.Secondary Outcome
Title Change in Fasting Triglycerides at 5 Weeks From Baseline
Hide Description Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame baseline and 5 weeks after dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description:
A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: mg/dl
-18  (12.9) -24  (9.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LoBAG30 Diet Control Diet
Hide Arm/Group Description

A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.

LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.

A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.

Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat

All-Cause Mortality
LoBAG30 Diet Control Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
LoBAG30 Diet Control Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LoBAG30 Diet Control Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Funding ended with only 14 subjects studied. With a parallel arm design, we were not able to draw any conclusions from the study. Funds were unavailable for a more sophisticated statistical analysis.
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: Mary C. Gannon, Ph.D.
Organization: Minneapolis VA Health Care System, Metabolic Research Labortory
Phone: 6124672895
EMail: ganno004@umn.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00607867    
Other Study ID Numbers: CLIN-010-07F
First Submitted: January 31, 2008
First Posted: February 6, 2008
Results First Submitted: November 17, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014