Diabetes MellitusLoBAG DietNCT00607867
LoBAG30 Diet in Patients on Metformin
A study testing LoBAG30 diet in people with Diabetes Mellitus and Diet, run by US Department of Veterans Affairs at 1 site in United States.
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%). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Diet
- What is being tested?
- LoBAG30 diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hematological abnormalities
- liver disease
- kidney disease
- macroalbuminuria (>300 mg albumin/24 hours)
- untreated thyroid disease
- congestive heart failure
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
About this study
Official title: Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Diet
- Being tested
- LoBAG30 diet, Control Diet
- Keywords
- Diabetes Mellitus (type 2), Diet, Glycohemoglobin, Lipids, Kidney Function, Glycemic Index, Dietary Protein, Dietary Carbohydrate
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoBAG30 dietOther
A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
Control DietOther
A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks. Receives: Other: LoBAG30 diet |
| Arm 2 | Placebo comparator | 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. Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in %Hemoglobin A1c at 5 Weeks From Baseline
Hemoglobin A1c measured before and after 5 weeks on the diet
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 5 weeks after dietary intervention
Secondary outcomes (2)
Microalbumin Excretion
change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention
Measured: baseline and 5 weeks after 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
Measured: baseline and 5 weeks after dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2011
- Study completionMar 2011
Why it stopped: The funding ended before the study was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary Gannon, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607867
- Sponsor's protocol ID
- CLIN-010-07F
- Acronym
- LoBAG Diet
- Status last verified
- Dec 2014
- First submitted
- 31 Jan 2008
- Last updated
- 12 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
- ClinicalTrials.gov ID
- NCT00607867
- Acronym / sponsor ID
- LoBAG Diet / CLIN-010-07F
- Conditions
- Diabetes Mellitus, Diet
- Keywords
- Diabetes Mellitus (type 2), Diet, Glycohemoglobin, Lipids, Kidney Function, Glycemic Index, Dietary Protein, Dietary Carbohydrate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding ended before the study was completed.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: LoBAG30 dietA LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks. |
| Arm 2 | Placebo comparator | Other: Control DietA 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (27 listed)
- Hematological abnormalities
- liver disease
- kidney disease
- macroalbuminuria (>300 mg albumin/24 hours)
- untreated thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoBAG30 dietA LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat. | Other | Arm 1 |
| Control DietA control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat | Other | Arm 2 |
Primary outcome
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.
2 secondary outcomes
Microalbumin Excretion
Time frame: baseline and 5 weeks after dietary intervention
Change in Fasting Triglycerides at 5 Weeks From Baseline
Time frame: baseline and 5 weeks after dietary intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Gannon, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoBAG30 diet in people with Diabetes Mellitus and Diet, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %Hemoglobin A1c at 5 Weeks From Baseline (time frame: Baseline and 5 weeks after dietary intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.