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Intermittent Fasting in Adults With Type 1 Diabetes

NCT ID: NCT06134986

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-09-01

Brief Summary

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The majority of adults with type 1 diabetes (T1DM) have either overweight or obesity. As such, dietary management has been recommended as an adjunct to insulin treatment to improve glycemic control and facilitate weight loss in patients with T1DM. Daily calorie restriction (CR) is the main diet prescribed to patients with T1DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. The simplicity of TRE, its accommodation of dietary preferences, and associated weight loss may translate to improved glycemic measures in patients with T1DM. The present study will be the first randomized controlled trial to compare the effect of TRE versus CR for weight management and improved glycemic control in adults with obesity and T1DM.

Detailed Description

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Conditions

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Type 1 Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Time restricted eating (TRE)

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 Type EXPERIMENTAL

Time restricted eating

Intervention Type OTHER

8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Daily calorie restriction (CR)

25% energy restriction every day Diet counseling provided

Group Type EXPERIMENTAL

Daily calorie restriction

Intervention Type OTHER

25% energy restriction every day Diet counseling provided

Control

Ad libitum food intake, eating over more than 10 hours per day

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Time restricted eating

8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Intervention Type OTHER

Daily calorie restriction

25% energy restriction every day Diet counseling provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 to 75 years old
* BMI between 25 and 50 kg/m2
* Previously diagnosed with T1DM and currently using insulin
* HbA1c: 6.5-9.5% (regardless of medication use)
* On either multiple daily doses of insulin (MDI) program or using an insulin pump (with or without closed loop feature) 11
* Active prescription for glucagon

Exclusion Criteria

* Previously diagnosed with T2DM
* Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
* Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
* Are not able to keep a food diary for 7 consecutive days during screening
* Are eating less than a 10-hour window at baseline
* Are pregnant, or trying to become pregnant
* Are night shift workers
* History of severe hypoglycemia defined as requiring help from others, needed to use emergency glucagon administration in the past 6 months.
* Other significant medical history including heart failure, unstable coronary artery disease, chronic obstructive pulmonary disease requiring oxygen, cirrhosis, active cancer, history of stroke, end stage renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Krista Varady

Professor of Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krista Varady, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Locations

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University of Illinois Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2023-0678

Identifier Type: -

Identifier Source: org_study_id