N/A N=48 Randomized Treatment

The LoBAG Diet and Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02717078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Change in Hemoglobin A1c From Baseline to Week 12 — 6.6; 7.2 percentage

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Diet Therapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hemoglobin A1c From Baseline to Week 12	6.6; 7.2	—
SECONDARY Change in Weight From Baseline to Week 12	—	—
SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 12	—	—
SECONDARY Change in Fasting Serum Insulin From Baseline to Week 12	—	—
SECONDARY Postprandial Plasma Glucose and Serum Insulin Following a Test Meal	—	—
SECONDARY Postprandial Plasma Glucose and Serum Insulin Following a Test Meal	—	—
SECONDARY Change in Serum Fructosamine From Baseline to Week 12	—	—
SECONDARY Change in Fasting Serum Lipids From Baseline to Week 12	—	—
SECONDARY Diabetes Treatment Satisfaction Questionnaire Score	—	—
SECONDARY Gut Microbiome Composition	—	—
SECONDARY Gut Microbiome Composition	—	—
SECONDARY Gut Microbiome Composition	—	—
SECONDARY Urine Nitrogen to Creatinine Ratio	—	—
SECONDARY Urine Nitrogen to Creatinine Ratio	—	—
SECONDARY Urine Nitrogen to Creatinine Ratio	—	—
SECONDARY Urine Nitrogen to Creatinine Ratio	—	—
SECONDARY Urine Nitrogen to Creatinine Ratio	—	—
SECONDARY Three-day Food Diary	—	—
SECONDARY Three-day Food Diary	—	—
SECONDARY Three-day Food Diary	—	—
SECONDARY 24-hour Diet Recall	—	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02717078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.