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Intermittent Fasting in Adults With Type 1 Diabetes

University of Illinois logo

University of Illinois

Status

Invitation-only

Conditions

Type 1 Diabetes
Obesity

Treatments

Other: Daily calorie restriction
Other: Time restricted eating

Study type

Interventional

Funder types

Other

Identifiers

NCT06134986
2023-0678

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Time restricted eating (TRE)
Experimental group
Description:
8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
Treatment:
Other: Time restricted eating
Daily calorie restriction (CR)
Experimental group
Description:
25% energy restriction every day Diet counseling provided
Treatment:
Other: Daily calorie restriction
Control
No Intervention group
Description:
Ad libitum food intake, eating over more than 10 hours per day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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