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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

SFS3 Trial 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.Check my eligibility
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.See study design
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.

SFS3 Trial 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.

SFS3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glycemic measures- HbA1c (12w)
Secondary outcome measures
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

SFS3 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
1,380 Previous Clinical Trials
1,588,685 Total Patients Enrolled
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
Type 2 Diabetes Research Study Groups: Time restricted eating, Caloric Restriction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this medical experiment still ongoing?

"Clinicaltrials.gov reports that the medical trial is actively looking for participants, with its initial posting on May 27th 2022 and last edit made on November 23rd 2022."

Answered by AI

Who are the eligible participants for this experimental research?

"Patients with diabetes mellitus between the ages of 18 and 50 can apply to be part of this clinical trial. A total of 60 individuals will be admitted for participation in the study."

Answered by AI

Does this research endeavor accept participants who are in their seventies or older?

"This clinical trial is accepting adults aged 18 and above, up to a maximum of 50 years old."

Answered by AI

How extensive is the current cohort for this research initiative?

"Affirmative. Per the information located on clinicaltrials.gov, this medical trial is presently recruiting individuals and has been since May 27th 2022. The most recent update was provided on November 23rd 2022 with a goal of 60 participants at one site."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent spike in A1c. Need help to get back on track.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
TRE in Type 2 Diabetes (See Food Study 3)
2022. "TRE in Type 2 Diabetes (See Food Study 3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05290246.
~15 spots leftby Jan 2025
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