NCT06134986Completed

Intermittent Fasting in Adults With Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 2 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 32 (actual)
First submitted: 11 Nov 2023
Start date: 20 Nov 2023
Primary completion date: 1 Sept 2025
Lead sponsor: University of Illinois Chicago
Diseases: Obesity, Type 1 diabetes
NCT number: NCT06134986

What you commit to

Study type: Interventional
Participants enrolled: 32
From 20 Nov 2023 to the primary completion date, 1 Sept 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previously diagnosed with T2DM
Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4%)
Are taking certain drugs that have significant weight loss outcomes (weight loss medications, specifically GLP1 agonist, GLP-1/GIP agonists)

Other illness

History of severe hypoglycemia defined as requiring help from others, needed to use emergency glucagon administration in the past 6 months.
Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)

Lab values

Medical history of heart failure, unstable coronary artery disease, chronic obstructive pulmonary disease, requiring oxygen, cirrhosis, active cancer, history of stroke, cognitive impairment, end stage renal disease (eGFR ≤30 ml/min/m2)

Other

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 perimenopausal (menses does not appear every 27-32d)
Are pregnant, or trying to become pregnant
Are night shift workers

Who the study is looking for

Previously diagnosed with T1DM and currently using insulin
HbA1c: 6.5-9.5% (regardless of medication use)
Age between 18 to 75 years old
BMI between 25 and 50 kg/m2
Independently living (i.e., subjects who do not live in a nursing home or institution)
On either multiple daily doses of insulin injections (MDII) or using an insulin pump (with or without closed loop feature)
Active prescription for daily use of a continous glucose monitor (CGM) or willing to be provided with a CGM during the study (at no cost)
Active prescription for glucagon

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Illinois Chicago Coordinator of this site? Confirm its status	Chicago	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.