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The funding ended before the study was completed.
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We will determine the metabolic response to a Low Biologically Available Glucose Diet (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in whom the glycohemoglobin is not at an acceptable level (>8.0%). Our hypothesis is that introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of metformin will improve blood glucose control in people who have not achieved an acceptable total glycohemoglobin on metformin alone.
Subjects will ingest a control diet (55% carbohydrate (CHO), 15% protein, 30% fat) or a LoBAG30 diet (30% CHO, 30% protein, 40% fat) in a parallel design with block randomization in pairs of two. Subjects will return to the study center twice each week while on the diets to have blood glucose, glycohemoglobin, lactate, weight and blood pressure measured, and to have urine assayed for urea and creatinine. At the beginning and end of the 5 week study period, the subjects will be admitted to the study center for 28 hours during which time blood will be drawn for 24 hour profiles of glucose, insulin, other hormones and several metabolites. For those subjects randomized to the LoBAG30 arm of the study, the control diet will be given during the first 24 hour study period; the assigned diet will be given at the end of the 5 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks. |
|
| Arm 2 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoBAG30 diet | Other | A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in %Hemoglobin A1c at 5 Weeks From Baseline | Hemoglobin A1c measured before and after 5 weeks on the diet | Baseline and 5 weeks after dietary intervention |
| Change in Total Glucose Area at 5 Weeks From Baseline | The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention. | Baseline and 5 weeks after dietary intervention |
| Change in Body Weight at 5 Weeks From Baseline | 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. | baseline and 5 weeks after dietary intervention |
| Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline | Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention. | baseline and 5 weeks after dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Microalbumin Excretion | change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention | baseline and 5 weeks after dietary intervention |
| Change in Fasting Triglycerides at 5 Weeks From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Hematological abnormalities
liver disease
kidney disease
macroalbuminuria (>300 mg albumin/24 hours)
untreated thyroid disease
congestive heart failure
angina
life-threatening malignancies
proliferative retinopathy
severe diabetic neuropathy
peripheral vascular disease
serious psychological disorders
a body mass index > 35
and a fasting triglyceride of >400 mg/dl.
insulin
the sulfonylureas
glucagon-like peptide 1 (GLP-1) analogs and metabolic inhibitors
pramlintide
prednisone and similar steroids
thyroid hormone
antipsychotic medications
thiazide diuretics
medroxyprogesterone
high dose aspirin, also will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Gannon, PhD | Minneapolis Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Minneapolis | Minneapolis | Minnesota | 55417 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LoBAG30 Diet | A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat |
| FG001 | Control Diet | A weight maintenance, control diet 55% CHO, 15% protein, 30% fat |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with type 2 diabetes being treated with metformin
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| ID | Title | Description |
|---|---|---|
| BG000 | LoBAG30 Diet | A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat. |
| BG001 | Control Diet | A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in %Hemoglobin A1c at 5 Weeks From Baseline | Hemoglobin A1c measured before and after 5 weeks on the diet | Posted | Mean | Standard Error | Change in % A1c at 5 weeks from baseli | Baseline and 5 weeks after dietary intervention |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LoBAG30 Diet | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary C. Gannon, Ph.D. | Minneapolis VA Health Care System, Metabolic Research Labortory | 6124672895 | ganno004@umn.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Control Diet | Other | A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat |
|
Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention
| baseline and 5 weeks after dietary intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Microalbumin Excretion | change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention | Posted | Mean | Standard Error | mg/day | baseline and 5 weeks after dietary intervention |
|
|
|
| Primary | Change in Total Glucose Area at 5 Weeks From Baseline | The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention. | Posted | Mean | Standard Error | mg hr/dl | Baseline and 5 weeks after dietary intervention |
|
|
|
| Primary | Change in Body Weight at 5 Weeks From Baseline | 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. | Posted | Mean | Standard Error | pounds | baseline and 5 weeks after dietary intervention |
|
|
|
| Primary | Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline | Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention. | Posted | Mean | Standard Error | mg/dl | baseline and 5 weeks after dietary intervention |
|
|
|
| Secondary | Change in Fasting Triglycerides at 5 Weeks From Baseline | Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention | Posted | Mean | Standard Error | mg/dl | baseline and 5 weeks after dietary intervention |
|
|
|
| 0 |
| 7 |
| 0 |
| 0 |
| EG001 | Control Diet | 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 | 0 | 7 | 0 | 0 |
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