Sleep Apnea SyndromesNCT00031239
Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD
An observational study of Sleep Apnea Syndromes and Diabetes Mellitus, Non-insulin Dependent, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Sleep Apnea Syndromes, Diabetes Mellitus, Non-insulin Dependent, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2001to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
An estimated 176 obese, diabetic subjects with obstructive sleep apnea, 50% women and 40% minorities.
About this study
To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.
Read the detailed description
BACKGROUND:
Weight loss is a frequently recommended treatment for obese patients with obstructive sleep apnea (OSA). The empirical support for this recommendation is lacking. Based on descriptive studies, weight loss appears to improve but not abolish sleep disordered breathing. Moreover, the degree of improvement in OSA is quite variable and not directly proportional to weight loss. The lack of randomized trials, the study of predominantly male samples, and the absence of follow-up evaluations leave physicians and patients unsure about the utility of weight loss treatment in obese OSA patients.
The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.
DESIGN NARRATIVE:
The study will assess the effects of weight loss on sleep disordered breathing in 120 obese, Type 2 diabetics with obstructive sleep apnea (respiratory disturbance index [RDI] greater than or equal to 15) who are randomly assigned to either weight loss (n=60) or usual care (n=60) treatments within the context of the Look AHEAD study. Home polysomnography studies will be performed before treatment and at one and two years. Among the 60 weight loss subjects, the investigators will assess the relative importance of changes in neck and abdominal fat in explaining the variability of changes in sleep disordered breathing after weight loss. Finally, they will examine the relationship between changes in sleep-disordered breathing and changes in blood pressure after weight loss in the 60 weight loss participants. Specifically, this research will: 1) determine the efficacy of a weight loss program in reducing sleep disordered breathing in obese Type 2 diabetics; 2) identify sources of variability in sleep disordered breathing associated with weight loss; and 3) examine the role of sleep disordered breathing in mediating changes in blood pressure associated with weight loss. The results of this study will provide an empirical basis for making recommendations about the effectiveness of weight loss in Type 2 diabetics with OSA.
- Conditions
- Sleep Apnea Syndromes, Diabetes Mellitus, Non-insulin Dependent, Obesity, Diabetes Mellitus
- Medical subject headings
- Sleep Apnea Syndromes, Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2002 (estimated)
- Study startSep 2001
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Gary Foster, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031239
- Sponsor's protocol ID
- 994
- Other IDs
- R01HL070301
- Status last verified
- May 2009
- First submitted
- 27 Feb 2002
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Foster GD. Principles and practices in the management of obesity. Am J Respir Crit Care Med. 2003 Aug 1;168(3):274-80. doi: 10.1164/rccm.200205-456PP. No abstract available.
PubMed 12888610
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD
- ClinicalTrials.gov ID
- NCT00031239
- Acronym / sponsor ID
- 994
- Conditions
- Sleep Apnea Syndromes, Diabetes Mellitus, Non-insulin Dependent, Obesity, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Feb 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.
Detailed description
BACKGROUND:
Weight loss is a frequently recommended treatment for obese patients with obstructive sleep apnea (OSA). The empirical support for this recommendation is lacking. Based on descriptive studies, weight loss appears to improve but not abolish sleep disordered breathing. Moreover, the degree of improvement in OSA is quite variable and not directly proportional to weight loss. The lack of randomized trials, the study of predominantly male samples, and the absence of follow-up evaluations leave physicians and patients unsure about the utility of weight loss treatment in obese OSA patients.
The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.
DESIGN NARRATIVE:
The study will assess the effects of weight loss on sleep disordered breathing in 120 obese, Type 2 diabetics with obstructive sleep apnea (respiratory disturbance index [RDI] greater than or equal to 15) who are randomly assigned to either weight loss (n=60) or usual care (n=60) treatments within the context of the Look AHEAD study. Home polysomnography studies will be performed before treatment and at one and two years. Among the 60 weight loss subjects, the investigators will assess the relative importance of changes in neck and abdominal fat in explaining the variability of changes in sleep disordered breathing after weight loss. Finally, they will examine the relationship between changes in sleep-disordered breathing and changes in blood pressure after weight loss in the 60 weight loss participants. Specifically, this research will: 1) determine the efficacy of a weight loss program in reducing sleep disordered breathing in obese Type 2 diabetics; 2) identify sources of variability in sleep disordered breathing associated with weight loss; and 3) examine the role of sleep disordered breathing in mediating changes in blood pressure associated with weight loss. The results of this study will provide an empirical basis for making recommendations about the effectiveness of weight loss in Type 2 diabetics with OSA.
Study design
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 12888610Foster GD. Principles and practices in the management of obesity. Am J Respir Crit Care Med. 2003 Aug 1;168(3):274-80. doi: 10.1164/rccm.200205-456PP. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Foster
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes and Diabetes Mellitus, Non-insulin Dependent, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00031239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.