The LoBAG Diet and Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Diet Therapy

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Bantle, MD; Phone Number: 612-625-8673; Email: d-study@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LoBAG Diet; 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; The intervention for both study groups will be a change in diet.
Active Comparator: Control Diet; Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.	Other: Diet Therapy; The intervention for both study groups will be a change in diet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Anne Bantle, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; diet; glucose; carbohydrate; protein
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MED-2016-23735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No