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Time Restricted Eating for Type 2 Diabetes

N/A
Waitlist Available
Led By Krista Varady
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI between 30 and 50 kg/m2
Age 18-80 years
Must not have
Have a history of cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, month 3, and month 6
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers understand if time restricted eating can help people with type 2 diabetes manage their weight and improve their glycemic control.

Who is the study for?
This trial is for adults aged 18-80 with obesity (BMI between 30 and 50) who have type 2 diabetes, with HbA1c levels between 6.5% and 11%. Participants should be sedentary or lightly active but not smokers, night shift workers, or those with a history of eating disorders or cardiovascular disease. They must also have been weight stable for the past three months.
What is being tested?
The study compares time restricted eating (TRE), where participants eat all their food from noon to 8 pm without counting calories, against daily calorie restriction (CR), which involves reducing energy intake by 25% each day. A control group eats over a period longer than ten hours per day. The goal is to see which method is better for losing weight and controlling blood sugar in people with obesity and type 2 diabetes.
What are the potential side effects?
While specific side effects are not detailed here, potential issues might include hunger outside of eating windows for TRE, difficulty maintaining reduced calorie intake for CR, changes in energy levels, mood swings due to dietary adjustments, and possible impacts on social life or sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 30 and 50.
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I am between 18 and 80 years old.
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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, month 3, and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, month 3, and month 6 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 percent body weight
Secondary study objectives
Adverse events
Change fasting glucose
Change fasting insulin
+20 more

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted feeding (TRF)Experimental Treatment1 Intervention
8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
Group II: Daily calorie restriction (CR)Experimental Treatment1 Intervention
25% energy restriction every day Diet counseling provided
Group III: ControlActive Control1 Intervention
Ad libitum food intake, eating over more than 10 hours per day

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,061 Total Patients Enrolled
3 Trials studying Diabetes
3,822 Patients Enrolled for Diabetes
Krista VaradyPrincipal InvestigatorUniversity of Illinois Chicago
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

Daily calorie restriction Clinical Trial Eligibility Overview. Trial Name: NCT05225337 — N/A
Diabetes Research Study Groups: Control, Time restricted feeding (TRF), Daily calorie restriction (CR)
Diabetes Clinical Trial 2023: Daily calorie restriction Highlights & Side Effects. Trial Name: NCT05225337 — N/A
Daily calorie restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225337 — N/A
~20 spots leftby Nov 2025
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