Type 1 Diabetes, Obesity
Conditions
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.
Interventions
OTHERTime 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)
25% energy restriction every day Diet counseling provided
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Previously diagnosed with T1DM and currently using insulin * HbA1c: 6.5-9.5% (regardless of medication use) * Age between 18 to 75 years old * BMI between 25 and 50 kg/m2 * Independently living (i.e., subjects who do not live in a nursing home or institution) * On either multiple daily doses of insulin injections (MDII) or using an insulin pump (with or without closed loop feature) * Active prescription for daily use of a continous glucose monitor (CGM) or willing to be provided with a CGM during the study (at no cost) * Active prescription for glucagon
Exclusion criteria
* History of severe hypoglycemia defined as requiring help from others, needed to use emergency glucagon administration in the past 6 months. * Medical history of heart failure, unstable coronary artery disease, chronic obstructive pulmonary disease, requiring oxygen, cirrhosis, active cancer, history of stroke, cognitive impairment, end stage renal disease (eGFR ≤30 ml/min/m2) * 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%) * Are not able to keep a food diary for 7 consecutive days during screening * Are taking certain drugs that have significant weight loss outcomes (weight loss medications, specifically GLP1 agonist, GLP-1/GIP agonists) * Are eating less than a 10-hour window at baseline * Are perimenopausal (menses does not appear every 27-32d) * Are pregnant, or trying to become pregnant * Are night shift workers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent body weight | Measured at baseline and month 6 | Measured by an electronic scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin dose | Measured at baseline and month 6 | Measured by recording total insulin dose, basal insulin dose, and bolus insulin dose |
| Change in HbA1c | Measured at baseline and month 6 | Measured by ELISA |
| 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 in standard deviation of glucose level | Measured at baseline and month 6 | Measured by continuous glucose monitor (CGM) |
| Change in coefficient of variation of glucose level | Measured at baseline and month 6 | Measured by continuous glucose monitor (CGM) |
| Change in absolute body weight | Measured at baseline and month 6 | Measured by an electronic scale |
| Change in fat mass, lean mass, visceral fat mass | Measured at baseline and month 6 | Measured by DXA |
| Change in waist circumference | Measured at baseline and month 6 | Measured by measuring tape |
| Change in body mass index (BMI) | Measured at baseline and month 6 | Calculated as kg/meter squared |
| Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) | Measured at baseline and month 6 | Measured using enzymatic kits, standardized reagents, and standardsand analyzed using a microplate reader |
| Change in systolic and diastolic blood pressure | Measured at baseline and month 6 | Measured by blood pressure cuff |
| Change in heart rate | Measured at baseline and month 6 | Measured by blood pressure cuff |
| Change in energy and nutrient intake | Measured at baseline and month 6 | Measured by 7-day food record |
| Change in dietary adherence | Measured at baseline and month 6 | Measured by 7-day food record and adherence log |
| Adverse events | Measured at baseline and month 6 | Measured by adverse events survey and continous glucose monitor (for events of hypoglycemia and hyperglycemia) |
| Change in physical activity (steps/d) | Measured at baseline and month 6 | Measured by activity monitor |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKrista Varady, PhD
University of Illinois Chicago
Outcome results
None listed