Status:
TERMINATED
LoBAG30 Diet in Patients on Metformin
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Diabetes Mellitus
Diet
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief 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...
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. Subj...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00607867
Start Date
April 1 2008
End Date
March 1 2011
Last Update
December 12 2014
Active Locations (1)
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1
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417