Clinical trial NCT06134986: Intermittent Fasting in Adults With Type 1 Diabetes
Official title: Intermittent Fasting in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in percent body weight
timeFrame: Measured at baseline and month 6
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Measured at baseline and month 6
measure: Change in total time in euglycemic range
timeFrame: Measured at baseline and month 6
measure: Change in mean glucose level
timeFrame: Measured at baseline and month 6
measure: Change in standard deviation of glucose level
timeFrame: Measured at baseline and month 6
measure: Change in coefficient of variation of glucose level
timeFrame: Measured at baseline and month 6
measure: Change fasting glucose
timeFrame: Measured at baseline and month 6
measure: Change in absolute body weight
timeFrame: Measured at baseline and month 6
measure: Change in fat mass, lean mass, visceral fat mass
timeFrame: Measured at baseline and month 6
measure: Change in waist circumference
timeFrame: Measured at baseline and month 6
measure: Change in body mass index (BMI)
timeFrame: Measured at baseline and month 6
measure: Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
timeFrame: Measured at baseline and month 6
measure: Change in systolic and diastolic blood pressure
timeFrame: Measured at baseline and month 6
measure: Change in heart rate
timeFrame: Measured at baseline and month 6
measure: Change in energy and nutrient intake
timeFrame: Measured at baseline and month 6
measure: Change in dietary adherence
timeFrame: Measured at baseline and month 6
measure: Change in physical activity (steps/d)
timeFrame: Measured at baseline and month 6
measure: Adverse events
timeFrame: Measured at baseline and month 6
measure: Change in medication effect score (MES)
timeFrame: Measured at baseline and month 6
measure: Change in ketones
timeFrame: Measured at baseline and month 6
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Krista Varady, PhD
role: PRINCIPAL_INVESTIGATOR
References: