Type 2 Diabetes MellitusNCT02717078
The LoBAG Diet and Type 2 Diabetes Mellitus
A study testing Diet Therapy in people with Type 2 Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
Trial summary
The proposed study is a randomized controlled, pilot effectiveness trial comparing the LoBAG diet to a control diet in 38 participants with DM2 over 12 weeks. Participants will have DM2 that is not under ideal glycemic control (HgbA1c 7.0-9.5%) and must be taking no glycemic medications or metformin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diet Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 14 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c of 7.0-9.5%
- Taking no medications for diabetes or taking metformin
Who cannot join
- Type 1 diabetes mellitus
- Treatment with insulin
- BMI < 27 kg/m^2
- Change in weight of more than 5 pounds in the prior 3 months
- Estimated glomerular filtration rate (GFR) < 60 ml/minute/1.73 m^2
- Urine albumin > 300 mg/g creatinine
Show all 13Show fewer
- Anemia
- Pregnancy or immediate plans to become pregnant
- Current breast feeding
- Use of antibiotics in the 3 month period prior to study enrollment
- Dietary restriction(s) that would preclude consumption of the study diets
- Inability or unwillingness to prepare meals
- Presence of any disease which would make adherence to the study protocol difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus
The proposed study is a randomized controlled, pilot effectiveness trial comparing the LoBAG diet to a control diet in 38 participants with DM2 over 12 weeks. Participants will have DM2 that is not under ideal glycemic control (HgbA1c 7.0-9.5%) and must be taking no glycemic medications or metformin. Participants will be free-living (given diet instruction and dietitian support, but asked to prepare meals in their own homes). The primary endpoint will be HgbA1c, measured at baseline and at the end of the 12-week diet intervention. Additional outcome measures will include: weight, fasting plasma glucose, fasting serum insulin, postprandial plasma glucose and serum insulin following a test meal consistent with the assigned diet, serum fructosamine, fasting serum lipids, stool samples for gut microbiome analysis, and surveys to assess quality of life, including the Diabetes Treatment Satisfaction Questionnaire. Compliance outcomes will include: urine nitrogen to creatinine ratio, survey data, three-day food diaries, and unannounced 24-hour diet recalls.
Read the detailed description
Thirty-eight adult men and women with DM2 will be recruited from the University of Minnesota and surrounding communities, and will be randomized to treatment with the LoBAG diet or a control diet. Following a consent and screening visit, there will be 5 additional study visits over a 12-week diet intervention period. Instruction in the assigned diet will be provided by a research dietitian at the beginning of the 12-week period, and reinforced at subsequent visits throughout the study. Participants will be asked to purchase food, prepare food, and consume the assigned diet in their own homes. They will be asked to keep activity level constant and to continue medications for diabetes (metformin or no medication) without change during the intervention. The primary outcome, HgbA1c, and secondary outcome measures will be assessed at baseline and following diet intervention. Study visits will occur at baseline (visits 1 and 2), week 1 (visit 3), week 6 (visit 4), week 9 (visit 5) and week 12 (final study visit). In addition to scheduled study visits the research team will contact participants every other week by telephone to address any issues that arise, with the purpose of increasing compliance and retention. Participants will be contacted once in weeks 9-12 for a 24-hour diet recall collected by the Nutrition Coordinating Center at the University of Minnesota. Study procedures will conclude after the 12-week diet intervention period and collection of all outcome measures.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diet Therapy
- Keywords
- diet, carbohydrate, protein, glucose, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet TherapyOther
The intervention for both study groups will be a change in diet.
| Study group | Role | What they receive |
|---|---|---|
| LoBAG Diet | Experimental | Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks. Receives: Other: Diet Therapy |
| Control Diet | Active comparator | Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks. Receives: Other: Diet Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c From Baseline to Week 12
Marker of blood sugar control
Measured: Week 12
Secondary outcomes (20)
Change in Weight From Baseline to Week 12
Weight in pounds
Measured: Week 12
Change in Fasting Plasma Glucose From Baseline to Week 12
Blood draw
Measured: Week 12
Change in Fasting Serum Insulin From Baseline to Week 12
Blood draw
Measured: Week 12
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Measured: Baseline
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Measured: Week 12
Change in Serum Fructosamine From Baseline to Week 12
A marker of blood sugar control, similar to hemoglobin A1c
Measured: Week 12
Change in Fasting Serum Lipids From Baseline to Week 12
Blood draw
Measured: Week 12
Diabetes Treatment Satisfaction Questionnaire Score
Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied)
Measured: Week 12
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Measured: Baseline
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Measured: Week 6
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Measured: Week 12
Urine Nitrogen to Creatinine Ratio
Urine sample
Measured: Baseline
Urine Nitrogen to Creatinine Ratio
Urine sample
Measured: Week 3
Urine Nitrogen to Creatinine Ratio
Urine sample
Measured: Week 6
Urine Nitrogen to Creatinine Ratio
Urine sample
Measured: Week 9
Urine Nitrogen to Creatinine Ratio
Urine sample
Measured: Week 12
Three-day Food Diary
Meal record for 3 days
Measured: Baseline
Three-day Food Diary
Meal record for 3 days
Measured: Week 6
Three-day Food Diary
Meal record for 3 days
Measured: Week 12
24-hour Diet Recall
Interview to review meals consumed in previous 24 hours
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start19 Jun 2017
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bantle, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717078
- Sponsor's protocol ID
- MED-2016-23735
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2016
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02717078
- Acronym / sponsor ID
- MED-2016-23735
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diet, carbohydrate, protein, glucose, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a randomized controlled, pilot effectiveness trial comparing the LoBAG diet to a control diet in 38 participants with DM2 over 12 weeks. Participants will have DM2 that is not under ideal glycemic control (HgbA1c 7.0-9.5%) and must be taking no glycemic medications or metformin. Participants will be free-living (given diet instruction and dietitian support, but asked to prepare meals in their own homes). The primary endpoint will be HgbA1c, measured at baseline and at the end of the 12-week diet intervention. Additional outcome measures will include: weight, fasting plasma glucose, fasting serum insulin, postprandial plasma glucose and serum insulin following a test meal consistent with the assigned diet, serum fructosamine, fasting serum lipids, stool samples for gut microbiome analysis, and surveys to assess quality of life, including the Diabetes Treatment Satisfaction Questionnaire. Compliance outcomes will include: urine nitrogen to creatinine ratio, survey data, three-day food diaries, and unannounced 24-hour diet recalls.
Detailed description
Thirty-eight adult men and women with DM2 will be recruited from the University of Minnesota and surrounding communities, and will be randomized to treatment with the LoBAG diet or a control diet. Following a consent and screening visit, there will be 5 additional study visits over a 12-week diet intervention period. Instruction in the assigned diet will be provided by a research dietitian at the beginning of the 12-week period, and reinforced at subsequent visits throughout the study. Participants will be asked to purchase food, prepare food, and consume the assigned diet in their own homes. They will be asked to keep activity level constant and to continue medications for diabetes (metformin or no medication) without change during the intervention. The primary outcome, HgbA1c, and secondary outcome measures will be assessed at baseline and following diet intervention. Study visits will occur at baseline (visits 1 and 2), week 1 (visit 3), week 6 (visit 4), week 9 (visit 5) and week 12 (final study visit). In addition to scheduled study visits the research team will contact participants every other week by telephone to address any issues that arise, with the purpose of increasing compliance and retention. Participants will be contacted once in weeks 9-12 for a 24-hour diet recall collected by the Nutrition Coordinating Center at the University of Minnesota. Study procedures will conclude after the 12-week diet intervention period and collection of all outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LoBAG Diet | Experimental | Other: Diet TherapyAssignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks. |
| Control Diet | Active comparator | Other: Diet TherapyAssignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c of 7.0-9.5%
- Taking no medications for diabetes or taking metformin
Key exclusion criteria (13 listed)
- Type 1 diabetes mellitus
- Treatment with insulin
- BMI < 27 kg/m^2
- Change in weight of more than 5 pounds in the prior 3 months
- Estimated glomerular filtration rate (GFR) < 60 ml/minute/1.73 m^2
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 |
|---|---|---|
| Diet TherapyThe intervention for both study groups will be a change in diet. | Other | Control Diet, LoBAG Diet |
Primary outcome
Change in Hemoglobin A1c From Baseline to Week 12
Time frame: Week 12
Marker of blood sugar control
20 secondary outcomes
Change in Weight From Baseline to Week 12
Time frame: Week 12
Change in Fasting Plasma Glucose From Baseline to Week 12
Time frame: Week 12
Change in Fasting Serum Insulin From Baseline to Week 12
Time frame: Week 12
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
Time frame: Baseline
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
Time frame: Week 12
Change in Serum Fructosamine From Baseline to Week 12
Time frame: Week 12
Change in Fasting Serum Lipids From Baseline to Week 12
Time frame: Week 12
Diabetes Treatment Satisfaction Questionnaire Score
Time frame: Week 12
Gut Microbiome Composition
Time frame: Baseline
Gut Microbiome Composition
Time frame: Week 6
Gut Microbiome Composition
Time frame: Week 12
Urine Nitrogen to Creatinine Ratio
Time frame: Baseline
Urine Nitrogen to Creatinine Ratio
Time frame: Week 3
Urine Nitrogen to Creatinine Ratio
Time frame: Week 6
Urine Nitrogen to Creatinine Ratio
Time frame: Week 9
Urine Nitrogen to Creatinine Ratio
Time frame: Week 12
Three-day Food Diary
Time frame: Baseline
Three-day Food Diary
Time frame: Week 6
Three-day Food Diary
Time frame: Week 12
24-hour Diet Recall
Time frame: Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anne Bantle, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Therapy in people with Type 2 Diabetes Mellitus, run by University of Minnesota 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 Jul 2024. 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. 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 26 Jul 2024). 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 From Baseline to Week 12 (time frame: Week 12). 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 26 Jul 2024.