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Intermittent Fasting for Type 1 Diabetes

N/A

Recruiting

Led By Krista Varady, PhD

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

On either multiple daily doses of insulin (MDI) program or using an insulin pump (with or without closed loop feature)

Age between 18 to 75 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and month 6

Awards & highlights

Study Summary

This trial will investigate whether a diet which limits the time you eat, rather than calories, can help people with type 1 diabetes lose weight and improve glycemic control.

Who is the study for?

Adults aged 18-75 with Type 1 Diabetes, a BMI of 25-50, and HbA1c levels between 6.5-9.5% are eligible for this trial if they're on insulin treatment and have been weight stable for the past three months. It's not suitable for those with eating disorders, pregnant women, night shift workers, or individuals with certain severe medical conditions.Check my eligibility

What is being tested?

The study is testing two dietary approaches to manage weight and improve blood sugar control in adults with obesity and Type 1 Diabetes: Time Restricted Eating (TRE), which limits food intake to a specific time window each day versus Daily Calorie Restriction (CR), where calorie intake is monitored daily.See study design

What are the potential side effects?

Potential side effects may include changes in blood sugar levels that could lead to hypoglycemia or hyperglycemia due to alterations in diet patterns. Participants should monitor their glucose closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use insulin multiple times a day or have an insulin pump.

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I am between 18 and 75 years old.

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I have type 1 diabetes and am using insulin.

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I have a current prescription for glucagon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and month 6 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 percent body weight

Secondary outcome measures

Adverse events

Change fasting glucose

Change in HbA1c

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Time restricted eating (TRE)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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,249 Total Patients Enrolled

33 Trials studying Obesity

9,763 Patients Enrolled for Obesity

Krista Varady, PhDPrincipal InvestigatorUniversity of Illinois Chicago

5 Previous Clinical Trials

601 Total Patients Enrolled

4 Trials studying Obesity

570 Patients Enrolled for Obesity

Frequently Asked Questions

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

How many participants is this research endeavor examining?

"Affirmative. The clinical trial is still looking for participants, as indicated by the information available on clinicaltrials.gov which was last updated on November 11th 2023. This medical study has to recruit a total of 60 individuals from one single location since its initial posting date of Novmeber 20th 2023."

Answered by AI

What are the requisite qualifications for partaking in this clinical experiment?

"All participants wishing to take part in this study must be between the ages of 18 and 75, as well as having been diagnosed with type 1 diabetes. A total of 60 positions are available for qualified applicants."

Answered by AI

Does this research offer participation to individuals aged seventy and above?

"The inclusion criteria for this trial specifies that applicants must be between 18 and 75 years of age. For participants under the legal age of consent, there are 395 clinical trials available to them while those over 65 have access to 1539 studies."

Answered by AI

Are there still openings in this medical trial for individuals?

"Affirmative. According to the information made available on clinicaltrials.gov, this experiment is actively seeking participants and was posted initially on November 20th 2022 with its most recent edit occuring on November 11th 2022. The trial requires a total of 60 individuals from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Fasting in Adults With Type 1 Diabetes

Krista Varady 2023. "Intermittent Fasting in Adults With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06134986.