Time Restricted Eating for the Treatment of Type 2 Diabetes
Study Details
Study Description
Brief Summary
Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. "Time restricted feeding" (TRF), and involves confining the period of food intake to 6-8 h per day. TRF allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRF is effective for weight loss and improved glycemic control in patients with prediabetes. However, no study to date has examined the effects of TRF in subjects with T2DM.
The present study will be the first to compare the effect of TRF versus CR for weight management and improved glycemic control in individuals with obesity and T2DM. This study will compare the effects of these diet regimens during 12-weeks of weight loss, followed by 12-weeks of weight maintenance on:
Specific aim 1: Body weight, energy restriction and dietary adherence
Specific aim 2: HbA1c, insulin sensitivity, and metabolic risk factors
Specific aim 3: T2DM remission, medication use, and occurrence of adverse events
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Time restricted feeding (TRF) 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 feeding (TRF)
8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
| Experimental: Daily calorie restriction (CR) 25% energy restriction every day Diet counseling provided |
Other: Daily calorie restriction
25% energy restriction every day Diet counseling provided
|
| No Intervention: Control Ad libitum food intake, no meal timing restrictions |
Outcome Measures
Primary Outcome Measures
- Change from baseline to week 24 in body weight [Measured at week 0 and 24]
Measured by an electronic scale
Secondary Outcome Measures
- Change from baseline to week 24 in fat mass and lean mass [Measured at week 0 and 24]
Measured by DXA
- Change from baseline to week 24 in Insulin resistance [Measured at week 0 and 24]
Measured as HOMA-IR
- Change from baseline to week 24 in Insulin sensitivity [Measured at week 0 and 24]
Measured as QUICKI
- Change from baseline to week 24 in HbA1c [Measured at week 0 and 24]
Measured by outside lab (Medstar, IN)
- Change from baseline to week 24 in fasting glucose [Measured at week 0 and 24]
Measured by outside lab (Medstar, IN)
- Change from baseline to week 24 in fasting insulin [Measured at week 0 and 24]
Measured by outside lab (Medstar, IN)
- Change from baseline to week 24 in plasma lipids [Measured at week 0 and 24]
Measured by outside lab (Medstar, IN)
- Change from baseline to week 24 in systolic and diastolic blood pressure [Measured at week 0 and 24]
Measured by blood pressure cuff
- Change from baseline to week 24 in heart rate [Measured at week 0 and 24]
Measured by blood pressure cuff
- Change from baseline to week 24 in inflammatory markers (IL-B) [Measured at week 0 and 24]
Measured by ELISA
- Change from baseline to week 24 in inflammatory marker (TNF-apha) [Measured at week 0 and 24]
Measured by ELISA
- Change from baseline to week 24 in inflammatory marker (IL-6) [Measured at week 0 and 24]
Measured by ELISA
- Change from baseline to week 24 in inflammatory marker (IL-10) [Measured at week 0 and 24]
Measured by ELISA
- Change from baseline to week 24 in inflammatory marker (C-reactive protein) [Measured at week 0 and 24]
Measured by ELISA
- Change from baseline to week 24 in energy and nutrient intake [Measured at week 0 and 24]
Measured by 7-day food record
- Change from baseline to week 24 in dietary adherence [Measured at week 0 and 24]
Measured by 7-day food record
- Change from baseline to week 24 in physical activity (steps/d) [Measured at week 0 and 24]
Measured by pedometer
- Change from baseline to week 24 in sleep quality and duration [Measured at week 0 and 24]
Measured by Pittsburgh Sleep Quality Index (PSQI). Total score of 0-21. A PSQI total score greater than 5 indicates poor sleep quality.
- Change from baseline to week 24 in mood [Measured at week 0 and 24]
Measured by 36-Item Short Form Survey (SF-36). Total score 0-100. Higher scores mean worse outcome.
- Change from baseline to week 24 in eating disorder symptoms [Measured at week 0 and 24]
Measured by Multifactorial Eating Disorder Survey
- Change from baseline to week 24 in adverse events [Measured at week 0 and 24]
Measured by survey
- Change from baseline to week 24 in diabetes remission [Measured at week 0 and 24]
Measured by survey
- Change from baseline to week 24 in medication effect score (MES) [Measured at week 0 and 24]
Measured by survey. Total score 0-100. Lower scores indicate less medication used, higher scores indicate more medication used.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
BMI between 27 and 50 kg/m2
-
T2DM (HbA1c: >6.5%)
-
Sedentary or lightly active
Exclusion Criteria:
-
Normoglycemic (HbA1c <5.7%) or have prediabetes: HbA1c: 5.7-6.4%
-
History of eating disorders (anorexia, bulimia, or binge eating disorder)
-
Not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
-
Not able to keep a food diary for 7 consecutive days during screening
-
Taking certain drugs that effect outcomes (weight loss medications)
-
Perimenopausal (menses does not appear every 27-32d)
-
Pregnant, or trying to become pregnant
-
Night shift workers
-
Smokers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Krista Varady, University of Illinois Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-1086