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Search / Trial NCT06134986

Intermittent Fasting in Adults With Type 1 Diabetes

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Nov 11, 2023

Trial Information

Current as of August 20, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This clinical trial is looking at how different eating patterns can help adults with type 1 diabetes (T1DM) who are also dealing with overweight or obesity. The researchers want to compare two approaches: traditional daily calorie restriction, where participants closely monitor and limit their calorie intake, and a new method called time-restricted eating (TRE). With TRE, participants will eat during a specific time frame of 6-8 hours each day, which may make it easier for them to stick to the diet while still allowing them to choose their foods. The goal is to see if either method can help manage blood sugar levels and support weight loss.

To be eligible for the trial, participants need to be between 18 and 75 years old, have a body mass index (BMI) between 25 and 50, and have been diagnosed with T1DM and using insulin. They should also have a specific range of blood sugar levels. However, people with a history of type 2 diabetes, eating disorders, or certain serious health conditions are not eligible. If you choose to participate, you can expect to follow one of the two eating plans and keep a food diary for the study duration. This trial is currently recruiting, and it represents an exciting opportunity to explore new dietary strategies for better health management in adults with type 1 diabetes.

Gender

ALL

Eligibility criteria

  • 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

About University Of Illinois At Chicago

The University of Illinois at Chicago (UIC) is a leading academic institution renowned for its commitment to advancing health sciences through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, UIC harnesses the expertise of its diverse faculty and state-of-the-art facilities to conduct cutting-edge clinical studies aimed at improving patient outcomes. The university's robust infrastructure for clinical research, combined with its dedication to ethical standards and regulatory compliance, positions UIC as a pivotal contributor to the development of new treatments and therapies in various medical fields. Through strategic partnerships and community engagement, UIC strives to translate research findings into real-world applications, enhancing the health and well-being of populations locally and globally.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Krista Varady, PhD

Principal Investigator

University of Illinois Chicago

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported