Clinical trial NCT02717078: The LoBAG Diet and Type 2 Diabetes Mellitus
Official title: A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diet
carbohydrate
protein
glucose
type 2 diabetes mellitus
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1c From Baseline to Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in Weight From Baseline to Week 12
timeFrame: Week 12
measure: Change in Fasting Plasma Glucose From Baseline to Week 12
timeFrame: Week 12
measure: Change in Fasting Serum Insulin From Baseline to Week 12
timeFrame: Week 12
measure: Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
timeFrame: Baseline
measure: Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
timeFrame: Week 12
measure: Change in Serum Fructosamine From Baseline to Week 12
timeFrame: Week 12
measure: Change in Fasting Serum Lipids From Baseline to Week 12
timeFrame: Week 12
measure: Diabetes Treatment Satisfaction Questionnaire Score
timeFrame: Week 12
measure: Gut Microbiome Composition
timeFrame: Baseline
measure: Gut Microbiome Composition
timeFrame: Week 6
measure: Gut Microbiome Composition
timeFrame: Week 12
measure: Urine Nitrogen to Creatinine Ratio
timeFrame: Baseline
measure: Urine Nitrogen to Creatinine Ratio
timeFrame: Week 3
measure: Urine Nitrogen to Creatinine Ratio
timeFrame: Week 6
measure: Urine Nitrogen to Creatinine Ratio
timeFrame: Week 9
measure: Urine Nitrogen to Creatinine Ratio
timeFrame: Week 12
measure: Three-day Food Diary
timeFrame: Baseline
measure: Three-day Food Diary
timeFrame: Week 6
measure: Three-day Food Diary
timeFrame: Week 12
measure: 24-hour Diet Recall
timeFrame: Week 9
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne Bantle, MD
role: PRINCIPAL_INVESTIGATOR
References: