N/A
Completed N=17
TRE With Physical Activity for Weight Management
Pre Diabetes · Overweight and Obesity
Source: ClinicalTrials.gov NCT04978376 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Body Weight Changes Between Week 1 to Week 10 — -2.1; -4.2; -1.3; .1 Percent body weight loss
Summary
Approximately 24 million older adults have prediabetes. Obesity, age related decreases in lean mass and increases in fat mass, and sedentary lifestyle have been associated with functional and cognitive decline in older adults. Innovative lifestyle strategies to treat obesity and pre-diabetes are critically needed. The proposed research will demonstrate that time restricted eating combined with resistance training is an effective non-pharmacological therapy to help obese prediabetic individuals reduce body fat, maintain lean mass, prevent progression of prediabetes to diabetes, and improve cognition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight Changes Between Week 1 to Week 10 |
-2.1; -4.2; -1.3; .1 | — |
| SECONDARY Body Composition Changes From Week 1 to Week 10 |
-3.5; -1.4; .7; -.3 | — |
| SECONDARY Change in Insulin From Week 1 to Week 10 |
-.9; .6; .3; 2 | — |
| SECONDARY Glucose |
-.5; 1.5; -5; 1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 50 to 70 years old
- BMI between 25 and 50 kg/m2
- Pre-diabetic or insulin resistant (fasting glucose: 100-125 mg/dl, HBA1c 5.7%-6.4%, or HOMA-IR >2.5)
- Sedentary or lightly active 24
- Are post menopausal (absence of menstrual cycle for 1 year)
Exclusion Criteria
- Diabetic (fasting glucose: >126 mg/dl or HBA1c >6.5%)
- Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- Have uncontrolled hypertension, any other cardiovascular disease, or history of aneurysm
- History of alcohol dependance (score >20 from Alcohol and Health Questionnaire)25
- 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 or activity log for 7 consecutive days during screening
- Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
- Are premenopausal, perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
- Mobility disability (unable to exercise for 40-60 minutes 3-5 days/week)
- Diagnosed comorbidities including systemic diseases (Parkinson's cirrhosis, renal disease or systemic rheumatic conditions), cancer, or cognitive impairment
- Are night shift workers
- Are smokers
Data sourced from ClinicalTrials.gov (NCT04978376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.