LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Diet	Other: LoBAG30 diet; Other: Control Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• 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
• Study Start Date: April 2008
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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.
4. 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 :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• 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

Locations

United States, Minnesota

VA Medical Center, Minneapolis

Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Mary Gannon, PhD; Minneapolis Veterans Affairs Medical Center

More Information

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00607867
• Other Study ID Numbers: CLIN-010-07F
• First Posted: February 6, 2008
• 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 ( US 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