Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01447251 · ClinicalTrials.gov registry record · NA
Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea
A NA study of Diabetes Mellitus and Obstructive Sleep Apnea, sponsored by Mike O'Callaghan Military Hospital.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01447251 is a NA study of Diabetes Mellitus and Obstructive Sleep Apnea that has completed, run by Mike O'Callaghan Military Hospital. The registered enrollment target is 70 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01447251, a NA study of Diabetes Mellitus and Obstructive Sleep Apnea, has completed, sponsored by Mike O'Callaghan Military Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators plan to recruit 140 patients (35 subjects in each group) over a period of 18 months in a prospective study of matched/paired case-control subjects across the four groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the 5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP) compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are given the result of the diabetes risk score; 2) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA. The investigators will document that the patients are compliant with CPAP based on review of SD card data recorded by the CPAP machine. Each patient will have serum drawn for the biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist circumference, smoking history, blood pressure, and other standard vital signs will also be collected. There will be no follow-up of the study subjects in groups 3 and 4 and their participation in this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after enrollment to assess whether or not there is any change in CPAP compliance as measured by SD card.
Conditions Studied
Interventions
- BEHAVIORAL PreDx Diabetes Risk Score
Study Locations (1)
Nevada
- Mike O'Callaghan Federal Hospital/Nellis AFB - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01447251
The ClinicalTrials.gov registry entry for NCT01447251 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (96% lower). The listed sponsor is Mike O'Callaghan Military Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which PreDx Diabetes Risk Score is the first listed.
NCT01447251 reports 1 study location spanning 1 distinct geographic area - top geographies include Nevada.
Frequently Asked Questions
What is clinical trial NCT01447251 about?
NCT01447251 is a clinical study titled "Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea". The investigators plan to recruit 140 patients (35 subjects in each group) over a period of 18 months in a prospective study of matched/paired case-control subjects across the four groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the 5-year risk of developing dia...
What is the current status of trial NCT01447251?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2011-09. Estimated completion is 2014-07.
What conditions does trial NCT01447251 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Obstructive Sleep Apnea.
What interventions are being tested in trial NCT01447251?
The interventions under investigation include: PreDx Diabetes Risk Score (BEHAVIORAL).
Who is sponsoring clinical trial NCT01447251?
This trial is sponsored by Mike O'Callaghan Military Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01447251 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Improving Glycemic Control With Telemedicine and Smart Insulin Pens
RECRUITING · NA
-
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
RECRUITING · NA
-
Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility
RECRUITING · NA
-
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
RECRUITING · NA
-
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
RECRUITING · NA
-
Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.