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LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

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ClinicalTrials.gov Identifier: NCT00607867
Recruitment Status : Terminated (The funding ended before the study was completed.)
First Posted : February 6, 2008
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 6, 2008
Results First Submitted Date  ICMJE November 17, 2014
Results First Posted Date  ICMJE December 12, 2014
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Total glycohemoglobin, 24 hour integrated plasma glucose concentration [ Time Frame: 5 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LoBAG30 Diet in Patients on Metformin
Official Title  ICMJE Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Diet
Intervention  ICMJE
  • Other: LoBAG30 diet
    A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
  • Other: Control Diet
    A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
Study Arms  ICMJE
  • Active Comparator: Arm 1
    A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
    Intervention: Other: LoBAG30 diet
  • 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.
    Intervention: Other: Control Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 5, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607867
Other Study ID Numbers  ICMJE CLIN-010-07F
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Gannon, PhD Minneapolis Veterans Affairs Medical Center
PRS Account VA Office of Research and Development
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP