LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00607867
First received: January 31, 2008
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Diet
Other: LoBAG30 diet
Other: Control Diet

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Total glycohemoglobin, 24 hour integrated plasma glucose concentration [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607867

Locations
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Gannon, PhD Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00607867     History of Changes
Other Study ID Numbers: CLIN-010-07F
Study First Received: January 31, 2008
Last Updated: January 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus (type 2)
Diet
Glycohemoglobin
Lipids
Kidney Function
Glycemic Index
Dietary Protein
Dietary Carbohydrate

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014