The LoBAG Diet and Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Diet Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoBAG Diet<br>Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks. | Other: Diet Therapy<br>* The intervention for both study groups will be a change in diet.<br>|
| Active Comparator: Control Diet<br>Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks. | Other: Diet Therapy<br>* The intervention for both study groups will be a change in diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c from baseline to week 12 | Marker of blood sugar control | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline to week 12 | Weight in pounds | Week 12 | 
| Change in fasting plasma glucose from baseline to week 12 | Blood draw | Week 12 | 
| Change in fasting serum insulin from baseline to week 12 | Blood draw | 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 | 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 | Week 12 | 
| Change in serum fructosamine from baseline to week 12 | A marker of blood sugar control, similar to hemoglobin A1c | Week 12 | 
| Change in fasting serum lipids from baseline to week 12 | Blood draw | Week 12 | 
| Diabetes Treatment Satisfaction Questionnaire score | Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied) | 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. | 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. | 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. | Week 12 | 
| Urine nitrogen to creatinine ratio | Urine sample | Baseline | 
| Urine nitrogen to creatinine ratio | Urine sample | Week 3 | 
| Urine nitrogen to creatinine ratio | Urine sample | Week 6 | 
| Urine nitrogen to creatinine ratio | Urine sample | Week 9 | 
| Urine nitrogen to creatinine ratio | Urine sample | Week 12 | 
| Three-day food diary | Meal record for 3 days | Baseline | 
| Three-day food diary | Meal record for 3 days | Week 6 | 
| Three-day food diary | Meal record for 3 days | Week 12 | 
| 24-hour diet recall | Interview to review meals consumed in previous 24 hours | Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, carbohydrate, protein, glucose, type 2 diabetes mellitus