Status:
ACTIVE_NOT_RECRUITING
TREAT to Improve Cardiometabolic Health
Lead Sponsor:
Columbia University
Collaborating Sponsors:
New York University
Salk Institute for Biological Studies
Conditions:
Overweight and Obesity
Prediabetes
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is dif...
Detailed Description
American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decrease cardiovascular risk, yet adherence to long term ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- age: 50-75y old
- BMI ≥25 and ≤45 kg/m2
- a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:
- diagnosis of hypertension on stable medication regimen
- blood pressure \>120/\>80 mmHg
- A diagnosis of dyslipidemia on stable regimen
- triglycerides 150 mg/dL
- HDL cholesterol men \<40 mg/dL and women \<50 mg/dL
- waist circumference men: \>102 cm (\>40 in); women \>88 cm (\>35 in)
- in possession of a smart phone (iPhone or Android)
- 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
- Sleep duration 6-h, with habitual self-reported wake up time \>5AM and before 11 AM and average self reported bed time \<2AM
- habitually eat breakfast
- with weight stability within 5% of screening for the last 3 months
- English speaking (the App has not yet been translated)
- must live in the New York City metro area
- Exclusion criteria:
- sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index \>30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
- significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
- history of seizure disorder
- previous bariatric surgery or on weight loss medication
- history of or current significant food intake or psychiatric disorder
- use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
- smoking tobacco or using illegal or recreational drugs
- consume excessive alcohol (women: \>14 drinks/wk; men: \>21 drinks/wk)
- anemia (hemoglobin \<10 g/dl and hematocrit \<30%)
- have conditions that render individual unable to complete all testing procedures \[e.g., unable to stay overnight or frequent travel across 1 time zones\]
- extreme early and late chronotypes (\> 2AM bed time and wake up time before 5AM and \> 11AM)
- severe food allergies
- unwilling/unable to provide informed consent
Exclusion
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04465721
Start Date
June 14 2021
End Date
June 30 2026
Last Update
May 18 2025
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032