Effect of Time-Restricted Eating on Blood Sugar and Heart Health in Adults with Prediabetes
Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
This study tests if changing when you eat can help adults with prediabetes improve their blood sugar levels and heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03504683 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of time-restricted eating (TRE) on glycemic control, blood pressure, and cardiovascular disease risk factors in adults diagnosed with prediabetes. Participants will be assigned to different eating schedules, including early TRE, mid-day TRE, and a control group, to assess the effects on their health metrics. The study aims to provide a controlled environment to evaluate whether the timing of food intake can lead to significant health improvements, even when total food intake is matched across groups.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30-70 with prediabetes, as indicated by specific blood glucose and insulin levels.
Not a fit: Patients who are already diagnosed with diabetes or those on medications affecting glucose metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a cost-effective dietary strategy to improve blood sugar control and reduce cardiovascular risks in individuals with prediabetes.
How similar studies have performed: Preliminary studies have shown promising results for time-restricted eating in improving health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 30-70 years old * Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1% * Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l * BMI between 30-60 kg/m\^2 * Wake up at a regular time between 5-8 am Exclusion Criteria: * Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure * On weight loss medication * Change in the dosage of a chronic medication within the past 2 months * Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels) * Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones * Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity * Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years * Pregnant or breastfeeding * Diagnosed psychiatric conditions * Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night * Major change in health or medical history in the past 3 months * Currently perform overnight shift work * Regularly eat within a \<10.5-hour period each day * Lost or gained more than 4% of weight in the past 2 months * Traveled more than 2 time zones away in the 2 months prior to enrolling in this study * Will travel outside the Central time zone in the 2 weeks prior to testing * Will travel more than 1 time zone away during this study * Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Courtney M. Peterson, Ph.D. — University of Alabama at Birmingham
- Study coordinator: Courtney M. Peterson, Ph.D.
- Email: cpeterso@uab.edu
- Phone: 205-934-0122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.