Study Summary
This trial will test whether following a set of stable lifestyle behaviors can help improve glucose control and body composition in patients with pre-diabetes.
Eligible Conditions
- Pre-diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 7 Secondary · Reporting Duration: 12 weeks
12 weeks
Adipose Tissue Measurement - Subcutaneous
Adipose Tissue Measurement - Total
Adipose Tissue Measurement - Visceral
Disposition Index
Glucose Area Under Curve
Liver Fat Content
Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose
Baseline, 12 weeks
Endothelial cell inflammation
Endothelial cell oxidative stress
Long-term Change in Glycemia
White blood cells
Week 12
Short-term Change in Glycemia
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Variable Schedule
1 of 4
Variable Sleep
1 of 4
Fixed Schedule
1 of 4
Fixed Sleep
1 of 4
Active Control
Experimental Treatment
34 Total Participants · 4 Treatment Groups
Primary Treatment: Fixed Sleep · No Placebo Group · N/A
Fixed Schedule
Behavioral
Experimental Group · 1 Intervention: Fixed Schedule · Intervention Types: BehavioralFixed Sleep
Behavioral
Experimental Group · 1 Intervention: Fixed Sleep · Intervention Types: BehavioralVariable ScheduleNoIntervention Group · 1 Intervention: Variable Schedule · Intervention Types:
Variable SleepNoIntervention Group · 1 Intervention: Variable Sleep · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,295 Previous Clinical Trials
1,613,237 Total Patients Enrolled
2 Trials studying Pre-diabetes
1,500 Patients Enrolled for Pre-diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,142 Previous Clinical Trials
4,064,471 Total Patients Enrolled
10 Trials studying Pre-diabetes
1,196 Patients Enrolled for Pre-diabetes
Department of Health and Human ServicesFED
201 Previous Clinical Trials
468,666 Total Patients Enrolled
Blandine LaferrerePrincipal InvestigatorColumbia University
Marie-Pierre St-OngePrincipal InvestigatorColumbia University
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have slept for 6 or more hours a night for 14 nights.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Columbia University Irving Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments