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Lifestyle Changes for Prediabetes

N/A
Recruiting
Led By Marie-Pierre St-Onge
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.4%)
35 years or older
Must not have
Obstructive Sleep Apnea
Psychiatric or neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults aged 35 or older with prediabetes, defined by specific blood sugar levels (hemoglobin A1c between 5.7-6.4%). Participants should have a BMI of 25-39.9 and sleep at least 6 hours nightly. Excluded are those with cardiovascular disease, certain kidney conditions, sleep apnea, recent weight loss programs, severe lipid problems, shift workers, substance abuse history, uncontrolled high blood pressure or psychiatric disorders.
What is being tested?
The study tests whether having a fixed schedule for daily activities can improve blood sugar control and body composition in people with prediabetes. It aims to see if stable lifestyle patterns reduce liver fat and help manage glucose levels better than variable lifestyles.
What are the potential side effects?
Since the intervention involves lifestyle adjustments rather than medication or medical procedures, side effects may include discomfort from changes in routine but no direct medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My A1c levels are between 5.7% and 6.4%, indicating pre-diabetes.
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I am 35 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with obstructive sleep apnea.
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I have a psychiatric or neurological condition.
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I have heart disease.
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My kidney function is reduced (GFR<60).
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My blood pressure is not higher than 160/100 mmHg.
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I am currently in a weight loss program or was in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adipose Tissue Measurement - Subcutaneous
Adipose Tissue Measurement - Total
Adipose Tissue Measurement - Visceral
+2 more
Secondary study objectives
Disposition Index
Endothelial cell inflammation (sub-set, n≤10)
Endothelial cell oxidative stress (sub-set, n≤10)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fixed ScheduleExperimental Treatment1 Intervention
Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.
Group II: Variable ScheduleActive Control1 Intervention
Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,385 Total Patients Enrolled
Department of Health and Human ServicesFED
232 Previous Clinical Trials
935,669 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,156 Total Patients Enrolled

Media Library

Fixed Schedule Clinical Trial Eligibility Overview. Trial Name: NCT05224986 — N/A
Prediabetes Research Study Groups: Variable Schedule, Fixed Schedule
Prediabetes Clinical Trial 2023: Fixed Schedule Highlights & Side Effects. Trial Name: NCT05224986 — N/A
Fixed Schedule 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224986 — N/A
~5 spots leftby Jun 2025
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