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
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus Diet | Other: LoBAG30 diet Other: Control Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1
A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
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Other: LoBAG30 diet
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat. |
Placebo Comparator: Arm 2
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.
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Other: Control Diet
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat |
- Change in %Hemoglobin A1c at 5 Weeks From Baseline [ Time Frame: Baseline and 5 weeks after dietary intervention ]Hemoglobin A1c measured before and after 5 weeks on the diet
- Change in Total Glucose Area at 5 Weeks From Baseline [ Time Frame: Baseline and 5 weeks after dietary intervention ]The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.
- Change in Body Weight at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]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.
- Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.
- Microalbumin Excretion [ Time Frame: baseline and 5 weeks after dietary intervention ]change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention
- Change in Fasting Triglycerides at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention

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Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- People with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day).
- These subjects will have had a stable glycohemoglobin (tGHb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study.
- Subjects with tGHB > 11% (HbA1c > 10%) will not be recruited into the study.
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
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and a fasting triglyceride of >400 mg/dl.
- Subjects taking slow-release metformin will not be studied.
- Subjects taking medications other than metformin, known to affect fuel metabolism such as:
- 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
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high dose aspirin, also will be excluded.
- If concentrations of serum folate, B12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.

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): NCT00607867
United States, Minnesota | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Mary Gannon, PhD | Minneapolis Veterans Affairs Medical Center |
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00607867 |
Other Study ID Numbers: |
CLIN-010-07F |
First Posted: | February 6, 2008 Key Record Dates |
Results First Posted: | December 12, 2014 |
Last Update Posted: | December 12, 2014 |
Last Verified: | December 2014 |
Diabetes Mellitus (type 2) Diet Glycohemoglobin Lipids |
Kidney Function Glycemic Index Dietary Protein Dietary Carbohydrate |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |