LoBAG30 Diet in Patients on Metformin

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Diet

In brief

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.

Key facts

Study ID

NCT00607867

Run by

US Department of Veterans Affairs

People needed

20

Starts

2008-04-01

Expected to finish

2011-03-01

Last updated by the study team

2014-12-12

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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