Obesity Clinical Trial
Official title:
Impact of Yo-Yo Sleep on Cardiometabolic Health
The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).
Status | Recruiting |
Enrollment | 72 |
Est. completion date | June 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: - Aged 18 to 49 years - BMI 20-29.9 kg/m2 - Habitually sleeping 7-9 hours/night without sleep aids or naps Exclusion Criteria: - Sleep disorders - Psychiatric disorders (including eating disorders) and seasonal affective disorder - Pregnancy (current/prior year) - Breastfeeding - Smokers (Any cigarette smoking or ex-smokers <3years) - Diabetes - Elevated blood pressure, taking beta-blockers - Individuals taking anti-coagulants or anti-platelets - Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure. - Travel across time zones; shift work (non-traditional hours) |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Icahn School of Medicine at Mount Sinai, National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting Plasma Glucose | Insulin resistance will be assessed by measuring fasting plasma glucose levels. | Up to 4 weeks | |
Primary | Insulin Level | Insulin resistance will be assessed by measuring insulin levels. | Up to 4 weeks | |
Primary | Morning Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 4 weeks | |
Primary | Evening Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 4 weeks | |
Primary | Fat mass | Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass. | Up to 4 weeks | |
Secondary | Low-density Lipoprotein (LDL) Level | Lipid panel will be assessed. | Up to 4 weeks | |
Secondary | High-density Lipoprotein (HDL) Level | Lipid panel will be assessed. | Up to 4 weeks | |
Secondary | Total Cholesterol Level | Lipid panel will be assessed. | Up to 4 weeks | |
Secondary | Triglyceride Level | Lipid panel will be assessed. | Up to 4 weeks | |
Secondary | C-reactive protein (CRP) Level | CRP will be measured as an inflammatory marker. | Up to 4 weeks | |
Secondary | Interleukin 6 (IL-6) | IL-6 will be measured as an inflammatory marker. | Up to 4 weeks | |
Secondary | Tumor necrosis factor alpha (TNF-alpha) | TNF-alpha will be measured as an inflammatory marker. | Up to 4 weeks | |
Secondary | Total daily energy expenditure | Energy expenditure will be measured using doubly-labeled water over 14 days | Baseline and endpoint (4 weeks) | |
Secondary | Energy Intake | Energy intake will be measured to assess diet quality using daily food records for 7 days. | Baseline and endpoint (4 weeks) | |
Secondary | Total Ghrelin | Total ghrelin will be assessed using radioimmunoassay (RIA). | 2 hours post meal at baseline and endpoint (4 weeks) | |
Secondary | Serum Leptin | Serum leptin will be measured using a double-antibody RIA. | 2 hours post meal at baseline and endpoint (4 weeks) | |
Secondary | Adiponectin Level | Adiponectin levels will be analyzed using RIA. | Up to 4 weeks | |
Secondary | Glucagon-like peptide 1 (GLP-1) Level | GLP-1 will be measured by RIA after plasma extraction with 95% ethanol. | 2 hours post meal at baseline and endpoint (4 weeks) | |
Secondary | Change in Nuclear factor kappa B (NFkB) Level | NFkB will be measured to assess endothelial cell inflammation. | Baseline and endpoint (4 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |