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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, month 3, and month 6
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, month 3, and month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, month 3, and month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in percent body weight
Secondary outcome measures
Adverse events
Change fasting glucose
Change fasting insulin
+17 moreTrial 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
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,280 Total Patients Enrolled
Krista VaradyPrincipal InvestigatorUniversity of Illinois Chicago
1 Previous Clinical Trials
52 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your HbA1c level is either too low (below 6.5) or too high (greater than 11%).Your HbA1c level is between 6.5% and 11%.You have a history of anorexia, bulimia, or binge eating disorder.You have eaten within 10 hours before the study starts.People who smoke.People who work at night.I am mostly inactive or lightly active.My BMI is between 30 and 50.My menstrual cycle is irregular.I have a history of heart disease.Your weight has changed by more than 4% in the last 3 months.I am between 18 and 80 years old.I have been diagnosed with type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Time restricted feeding (TRF)
- Group 3: Daily calorie restriction (CR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research opportunity open for recruitment now?
"According to clinicaltrials.gov, this medical study is no longer recruiting participants as it was initially listed on January 25th 2022 and last modified on February 3rd 2022. However, there are still 2259 other trials accepting patients at the moment."
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