Intermittent Fasting in Adults With Type 1 Diabetes

Not Applicable

• Conditions: Obesity; Type 1 Diabetes
• Interventions: Other: Time restricted eating; Other: Daily calorie restriction

• Registration Number: NCT06134986
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-11
• Study First Posted: 2023-11-18
• Study Start: 2023-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time restricted eating (TRE)	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)
Daily calorie restriction (CR)	Daily calorie restriction	25% energy restriction every day Diet counseling provided

Primary Outcome Measures

Name	Time	Method
Change in percent body weight	Measured at baseline and month 6	Measured by an electronic scale

Secondary Outcome Measures

Name	Time	Method
Change in body mass index (BMI)	Measured at baseline and month 6	Calculated as kg/meter squared
Change in energy and nutrient intake	Measured at baseline and month 6	Measured by 7-day food record
Change in standard deviation of glucose level	Measured at baseline and month 6	Measured by continuous glucose monitor (CGM)
Change in heart rate	Measured at baseline and month 6	Measured by blood pressure cuff
Change in dietary adherence	Measured at baseline and month 6	Measured by 7-day food record and adherence log
Change in ketones	Measured at baseline and month 6	Measured by ketone meter
Change in physical activity (steps/d)	Measured at baseline and month 6	Measured by activity monitor
Change in systolic and diastolic blood pressure	Measured at baseline and month 6	Measured by blood pressure cuff
Change in total time in euglycemic range	Measured at baseline and month 6	Measured by continuous glucose monitor (CGM)
Change in mean glucose level	Measured at baseline and month 6	Measured by continuous glucose monitor (CGM)
Change fasting glucose	Measured at baseline and month 6	Measured by outside lab (Medstar, IN)
Change in absolute body weight	Measured at baseline and month 6	Measured by an electronic scale
Change in waist circumference	Measured at baseline and month 6	Measured by measuring tape
Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)	Measured at baseline and month 6	Measured by outside lab (Medstar, IN)
Adverse events	Measured at baseline and month 6	Measured by adverse events survey
Change in medication effect score (MES)	Measured at baseline and month 6	Measured by survey. Total score 0-100. Lower scores indicate less medication used, higher scores indicate more medication used.
Change in HbA1c	Measured at baseline and month 6	Measured by outside lab (Medstar, IN)
Change in coefficient of variation of glucose level	Measured at baseline and month 6	Measured by continuous glucose monitor (CGM)
Change in fat mass, lean mass, visceral fat mass	Measured at baseline and month 6	Measured by DXA

Trial Locations

Locations (1)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States