LoBAG30 Diet in Patients on Metformin

NCT ID: NCT00607867

Last Updated: 2014-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-03-31

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 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

Keywords

Diabetes Mellitus (type 2); Diet; Glycohemoglobin; Lipids; Kidney Function; Glycemic Index; Dietary Protein; Dietary Carbohydrate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.

Group Type: ACTIVE_COMPARATOR

LoBAG30 diet

Intervention Type: OTHER

A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.

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.

Group Type: PLACEBO_COMPARATOR

Control Diet

Intervention Type: OTHER

A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat

Interventions

LoBAG30 diet

A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.

Intervention Type: OTHER

Control Diet

A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Gannon, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

VA Medical Center, Minneapolis

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CLIN-010-07F

Identifier Type: -

Identifier Source: org_study_id