LoBAG30 Diet in Patients on Metformin

Diabetes Mellitus Clinical Trial

— LoBAG Diet  

Official title:

Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607867
• Other study ID #: CLIN-010-07F
• Status: Terminated
• Phase: N/A
• First received: January 31, 2008
• Last updated: December 10, 2014
• Start date: April 2008
• Est. completion date: March 2011

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diet

Intervention

Other:
• LoBAG30 diet
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
• Control Diet
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat

Locations

Country	Name	City	State
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in %Hemoglobin A1c at 5 Weeks From Baseline	Hemoglobin A1c measured before and after 5 weeks on the diet	Baseline and 5 weeks after dietary intervention	No
Primary	Change in Total Glucose Area at 5 Weeks From Baseline	The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.	Baseline and 5 weeks after dietary intervention	No
Primary	Change in Body Weight at 5 Weeks From Baseline	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.	baseline and 5 weeks after dietary intervention	No
Primary	Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline	Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.	baseline and 5 weeks after dietary intervention	No
Secondary	Microalbumin Excretion	change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention	baseline and 5 weeks after dietary intervention	No
Secondary	Change in Fasting Triglycerides at 5 Weeks From Baseline	Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention	baseline and 5 weeks after dietary intervention	No