NCT05225337Completed
Time Restricted Eating for the Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. At present, daily calorie restriction (CR) is the main diet prescribed to patients with T2DM 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. Recent findings show that TRE is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. However no long-term randomized controlled trial has examined whether TRE is safe and effective for patients with obesity and T2DM. This study is a 6-month randomized, controlled trial that aims to compare the effects of TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and T2DM.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 25 Jan 2022
- Start date
- Feb 2022
- Primary completion date
- Apr 2023
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05225337
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From Feb 2022 to the primary completion date, Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4%)
Other illness
- Have a history of cardiovascular disease
- History of eating disorders (anorexia, bulimia, or binge eating disorder)
Lab values
- HbA1c below 6.5 or greater than 11%
Other
- Eating within less than a 10 hour window at baseline
- Perimenopausal (menses does not appear every 27-32d)
- Pregnant, or trying to become pregnant
- Night shift workers
- Smokers
Who the study is looking for
- Age 18-80 years
- BMI between 30 and 50 kg/m2
- Previously diagnosed with type 2 diabetes
- HbA1c between 6.5 and 11%
- Sedentary or lightly active
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.