RECRUITING

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

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Conditions

PreDiabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-08-17
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03504683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 30-70 years old
  2. * Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1%
  3. * Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l
  4. * BMI between 30-60 kg/m\^2
  5. * Wake up at a regular time between 5-8 am
  1. * Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
  2. * On weight loss medication
  3. * Change in the dosage of a chronic medication within the past 2 months
  4. * Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  5. * Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
  6. * Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
  7. * Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  8. * Pregnant or breastfeeding
  9. * Diagnosed psychiatric conditions
  10. * Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
  11. * Major change in health or medical history in the past 3 months
  12. * Currently perform overnight shift work
  13. * Regularly eat within a \<10.5-hour period each day
  14. * Lost or gained more than 4% of weight in the past 2 months
  15. * Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
  16. * Will travel outside the Central time zone in the 2 weeks prior to testing
  17. * Will travel more than 1 time zone away during this study
  18. * Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements

Contacts and Locations

Study Contact

Courtney M. Peterson, Ph.D.
CONTACT
205-934-0122
cpeterso@uab.edu
Harper Basquill, B.S.N.
CONTACT
205-934-5458
habasquill@uabmc.edu

Principal Investigator

Courtney M. Peterson, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Courtney M. Peterson, Ph.D., PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-17
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2020-08-17
Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • PreDiabetes