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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
Change in %Hemoglobin A1c at 5 Weeks From Baseline
Hemoglobin A1c measured before and after 5 weeks on the diet
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 5 weeks after dietary intervention
Microalbumin Excretion
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
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
Time frame: baseline and 5 weeks after dietary intervention
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