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Time Restricted Eating for Type 2 Diabetes (SFS3 Trial)

N/A
Recruiting
Led By Lisa Chow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Overweight/obese adults with metformin-only treated type 2 diabetes
Aged 18-65 years old
Must not have
Type 2 diabetes treated with medications other than metformin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if time restricted eating (TRE), which involves restricting the eating window, is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients with Type 2 diabetes.

Who is the study for?
This trial is for adults aged 18-65 with Type 2 diabetes treated only with metformin, having a BMI of 25-40 and stable weight. Participants should have an HbA1c level between 6.5-8.5% and own a smartphone. Pregnant individuals, those on other diabetes medications besides metformin, or with eating disorders cannot join.
What is being tested?
The study is testing if time restricted eating (TRE), where participants eat during a fixed daily window without calorie counting, can improve blood sugar levels compared to traditional caloric restriction over a period of 24 weeks in overweight/obese patients.
What are the potential side effects?
While the trial's description does not specify side effects, TRE may lead to hunger outside of eating windows, potential overeating during allowed times, and changes in energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am overweight and have type 2 diabetes treated only with metformin.
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am being treated for Type 2 diabetes with medication other than metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in glycemic measures- HbA1c (12w)
Secondary study objectives
Change in glycemic measures- HbA1c (24w)
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (24w)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eatingExperimental Treatment1 Intervention
daily 8 hour eating window
Group II: Caloric RestrictionActive Control1 Intervention
reduction of caloric intake by 15%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2021
N/A
~130

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,583 Total Patients Enrolled
3 Trials studying Diabetes
834 Patients Enrolled for Diabetes
Lisa Chow, MDPrincipal InvestigatorUniversity of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
3 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Caloric reduction Clinical Trial Eligibility Overview. Trial Name: NCT05290246 — N/A
Diabetes Research Study Groups: Time restricted eating, Caloric Restriction
~2 spots leftby Jan 2025
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