LoBAG30 Diet in Patients on Metformin (LoBAG Diet)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin|
- Total glycohemoglobin, 24 hour integrated plasma glucose concentration [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Adverse effect on microalbumin excretion (appearance or progression) and creatinine clearance (>10% decrease) and/or an adverse effect on lactate and/or lipids (>10% increase in LDL-cholesterol and/or >10 decrease in HDL-cholesterol). [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
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.
Other: Control Diet
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
Subjects will ingest a control diet (55% 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.
|United States, Minnesota|
|VA Medical Center, Minneapolis|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Mary Gannon, PhD||Minneapolis Veterans Affairs Medical Center|