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LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

Primary Purpose

Diabetes Mellitus, Diet

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LoBAG30 diet
Control Diet
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus (type 2), Diet, Glycohemoglobin, Lipids, Kidney Function, Glycemic Index, Dietary Protein, Dietary Carbohydrate

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical Center, Minneapolis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.

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.

Outcomes

Primary Outcome Measures

Change in %Hemoglobin A1c at 5 Weeks From Baseline
Hemoglobin A1c measured before and after 5 weeks on the diet
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.
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.
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.

Secondary Outcome Measures

Microalbumin Excretion
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
Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention

Full Information

First Posted
January 31, 2008
Last Updated
December 10, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00607867
Brief Title
LoBAG30 Diet in Patients on Metformin
Acronym
LoBAG Diet
Official Title
Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
The funding ended before the study was completed.
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diet
Keywords
Diabetes Mellitus (type 2), Diet, Glycohemoglobin, Lipids, Kidney Function, Glycemic Index, Dietary Protein, Dietary Carbohydrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
LoBAG30 diet
Intervention Description
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
Intervention Type
Other
Intervention Name(s)
Control Diet
Intervention Description
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
Primary Outcome Measure Information:
Title
Change in %Hemoglobin A1c at 5 Weeks From Baseline
Description
Hemoglobin A1c measured before and after 5 weeks on the diet
Time Frame
Baseline and 5 weeks after dietary intervention
Title
Change in Total Glucose Area at 5 Weeks From Baseline
Description
The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.
Time Frame
Baseline and 5 weeks after dietary intervention
Title
Change in Body Weight at 5 Weeks From Baseline
Description
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.
Time Frame
baseline and 5 weeks after dietary intervention
Title
Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline
Description
Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.
Time Frame
baseline and 5 weeks after dietary intervention
Secondary Outcome Measure Information:
Title
Microalbumin Excretion
Description
change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame
baseline and 5 weeks after dietary intervention
Title
Change in Fasting Triglycerides at 5 Weeks From Baseline
Description
Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame
baseline and 5 weeks after dietary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Gannon, PhD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

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LoBAG30 Diet in Patients on Metformin

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