ACTIVE_NOT_RECRUITING

TRE in Type 2 Diabetes (See Food Study 3)

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

Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-45 kg/m2\] with metformin-only treated Type 2 diabetes.

Official Title

TRE in Type 2 Diabetes Mellitus (See Food Study 3)

Quick Facts

Study Start:2022-05-27
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05290246

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Overweight/obese adults with metformin-only treated type 2 diabetes
  2. * 18-65 years old
  3. * BMI:25-45 kg/m2
  4. * HbA1c: 6.5-8.5%
  5. * Self-reported weight must be stable \[±5 pounds\] for at least 3 months prior to the study
  6. * Owns a smartphone.
  1. * Active or anticipated pregnancy during the study
  2. * type 2 diabetes treated with medications other than metformin
  3. * presence of eating disorders as noted by screening survey.

Contacts and Locations

Principal Investigator

Lisa Chow, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Lisa Chow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

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 Date2022-05-27
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-05-27
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Type 2 diabetes
  • diet intervention
  • intermittent fasting
  • caloric restriction
  • time restricted eating

Additional Relevant MeSH Terms

  • Type2Diabetes