Intermittent Fasting in Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Intermittent Fasting in Adults With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Obesity

Intervention / Treatment
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* Other: Time restricted eating
* Other: Daily calorie restriction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent body weight | Measured by an electronic scale | Measured at baseline and month 6 | 

Secondary Outcome Measures

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