The LoBAG Diet and Type 2 Diabetes Mellitus

NCT02717078 | Completed Results

• 1 other identifier: MED-2016-23735
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diet; carbohydrate; protein; glucose; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c From Baseline to Week 12

  Marker of blood sugar control

  Week 12

Secondary Outcomes (20)

• Change in Weight From Baseline to Week 12

  Week 12

• Change in Fasting Plasma Glucose From Baseline to Week 12

  Week 12

• Change in Fasting Serum Insulin From Baseline to Week 12

  Week 12

• Postprandial Plasma Glucose and Serum Insulin Following a Test Meal

  Baseline

• Postprandial Plasma Glucose and Serum Insulin Following a Test Meal

  Week 12

Study Arms (2)

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.

Other: Diet Therapy

Control Diet

ACTIVE COMPARATOR

Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.

Other: Diet Therapy

Interventions

Diet Therapy OTHER

The intervention for both study groups will be a change in diet.

Control Diet; LoBAG Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Anne Bantle
• Organization: University of Minnesota

endofixer@umn.edu

612-625-8673

Study Officials

• Anne Bantle, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: June 19, 2017
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)