NCT00607867

LoBAG30 Diet in Patients on Metformin

Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus
• Diet

Interventions

Type	Name	Description
OTHER	LoBAG30 diet	A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
OTHER	Control Diet	A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2008-02-06
• Last updated: 2014-12-12
• Results posted: 2014-12-12

Locations

1 site across 1 country: United States