Study Stopped
The funding ended before the study was completed.
LoBAG30 Diet in Patients on Metformin
LoBAG Diet
Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Apr 2008
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
December 12, 2014
CompletedDecember 12, 2014
December 1, 2014
2.8 years
January 31, 2008
November 17, 2014
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Secondary Outcomes (2)
Microalbumin Excretion
baseline and 5 weeks after dietary intervention
Change in Fasting Triglycerides at 5 Weeks From Baseline
baseline and 5 weeks after dietary intervention
Study Arms (2)
Arm 1
ACTIVE COMPARATORA LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
Arm 2
PLACEBO COMPARATORA 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.
Interventions
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Funding ended with only 14 subjects studied. With a parallel arm design, we were not able to draw any conclusions from the study. Funds were unavailable for a more sophisticated statistical analysis.
Results Point of Contact
- Title
- Mary C. Gannon, Ph.D.
- Organization
- Minneapolis VA Health Care System, Metabolic Research Labortory
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Gannon, PhD
Minneapolis Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 6, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2011
Study Completion
March 1, 2011
Last Updated
December 12, 2014
Results First Posted
December 12, 2014
Record last verified: 2014-12