Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \ 8 am-3 pm), (2) 'Mid-day TRE' (eat between \ 1 pm - 8 pm), or (3) Control Schedule (\ 8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged 30-70 years old

• Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1%

• Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l

• BMI between 30-60 kg/m\^2

• Wake up at a regular time between 5-8 am

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Courtney M. Peterson, Ph.D.
cpeterso@uab.edu
205-934-0122
Backup
Harper Basquill, B.S.N.
habasquill@uabmc.edu
205-934-5458
Time Frame
Start Date: 2020-08-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 144
Treatments
Experimental: Early TRE
Experimental: Mid-day TRE
Placebo_comparator: Control Schedule
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov