Health TrialsbyHealthPanel

Lifestyle Patterns and Glycemic Control

ConditionPre-diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorColumbia University

About this trial

The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes.

The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%)

25 years or older

BMI between 25-39.9 kg/m2

Sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights)

Disqualifiers

Chronic Kidney Disease (GFR<60)

Uncontrolled hypertension (≥160/100 mmHg)

Obstructive Sleep Apnea

Psychiatric or neurological disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fixed Schedule

    Behavioral

    Participants will be asked to maintain a fixed schedule for 12 weeks.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Variable ScheduleNo intervention 0 interventions
Group B: Fixed ScheduleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adipose Tissue Measurement - Total

Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.

Time frame
12 weeks
2

Adipose Tissue Measurement - Subcutaneous

Measurement of subcutaneous adiposity using MRI.

Time frame
12 weeks
3

Adipose Tissue Measurement - Visceral

Measurement of visceral adiposity using MRI.

Time frame
12 weeks
4

Glucose Area Under Curve

Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.

Time frame
12 weeks

Secondary outcomes

1

Liver Fat Content

This is to assess liver fat measured by MRS and MRI in %.

Time frame
12 weeks
2

Disposition Index

This is to assess disposition index, measured using HOMA-IR. The disposition index is the product of the insulogenic index and homeostatic model of assessment for insulin resistance.

Time frame
12 weeks
3

Short-term Change in Glycemia

Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.

Time frame
Baseline, up to 12 weeks
4

Endothelial cell inflammation (sub-set, n≤10)

NF-κB nuclear fluorescence area for pilot study.

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Department of Health and Human Services

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now