Intermittent Fasting in Adults With Type 1 Diabetes

Obesity Clinical Trial

Official title:

Intermittent Fasting in Adults With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134986
• Other study ID #: 2023-0678
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: Krista Varady, PhD
• Phone: 3129967897
• Email: varady[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Obesity
• Type 1 Diabetes

Intervention

Other:
• 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
25% energy restriction every day Diet counseling provided

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

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