NCT02717078

The LoBAG Diet and Type 2 Diabetes Mellitus

Completed NA Results posted Last updated 26 July 2024

What this trial tests

NA trial testing Diet Therapy in Type 2 Diabetes Mellitus in 48 participants. Completed in 14 February 2023.

Timeline

19 June 2017

Primary endpoint
14 February 2023

14 February 2023

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	19 June 2017
Primary completion	14 February 2023
Estimated completion	14 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Diet Therapy

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hemoglobin A1c From Baseline to Week 12 Primary · Week 12

Marker of blood sugar control

Group	Value	95% CI
LoBAG Diet	6.6	± 0.6
Control Diet	7.2	± 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LoBAG Diet

Serious: 0/24 (0%)

Deaths: 0/24

Control Diet

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (7 terms — click to expand)

Reaction	System	LoBAG Diet	Control Diet
Nausea	General disorders	—	—
tingling/neuropathy symptoms	Nervous system disorders	—	—
constipation	Gastrointestinal disorders	—	—
ear infection	Ear and labyrinth disorders	—	—
arm pain	General disorders	—	—
kidney stone	Renal and urinary disorders	—	—
back injury	General disorders	—	—

Data from ClinicalTrials.gov NCT02717078 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Modulating the Microbiota as a Therapeutic Intervention for Type 2 Diabetes.
   Huda MN, Kim M, Bennett BJ. · · 2021 · cited 89× · PMID 33897618 · DOI 10.3389/fendo.2021.632335