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LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

This study has been terminated.
(The funding ended before the study was completed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607867
First Posted: February 6, 2008
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: None (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 VA Office of Research and Development:

Primary Outcome Measures:
  • Change in %Hemoglobin A1c at 5 Weeks From Baseline [ Time Frame: Baseline and 5 weeks after dietary intervention ]
    Hemoglobin A1c measured before and after 5 weeks on the diet

  • Change in Total Glucose Area at 5 Weeks From Baseline [ Time Frame: Baseline and 5 weeks after dietary intervention ]
    The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.

  • Change in Body Weight at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]
    Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.

  • Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]
    Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.


Secondary Outcome Measures:
  • Microalbumin Excretion [ Time Frame: baseline and 5 weeks after dietary intervention ]
    change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention

  • Change in Fasting Triglycerides at 5 Weeks From Baseline [ Time Frame: baseline and 5 weeks after dietary intervention ]
    Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention


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% 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.
  Eligibility

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607867


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00607867     History of Changes
Other Study ID Numbers: CLIN-010-07F
First Submitted: January 31, 2008
First Posted: February 6, 2008
Results First Submitted: November 17, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
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