Fixed Sleep for Pre-diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pre-diabetesFixed Sleep - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

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: Behavioral
Fixed Sleep
Behavioral
Experimental Group · 1 Intervention: Fixed Sleep · Intervention Types: Behavioral
Variable 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 York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Columbia University Irving Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%