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Diabetes sleep treatment trial: Premise, design, and methodology.

ABSTRACT: The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, the study design, and the methodology used in this on-going trial. The target enrollment is 210 randomly assigned participants recruited from two sites. The primary outcome for glucose control is HbA1C; additional outcomes for diabetes self-management include objectively measured steps walked and subjectively measured diabetes-related distress, diabetes empowerment, and diabetes knowledge. All participants receive individual diabetes education and counseling for 6?weeks over two individual sessions and three telephone calls. Participants are randomized to receive either sham or active CPAP for 12?weeks, after which, they "guess" their group assignment; this will assist in determining the success of blinding participants to treatment group assignment. Participants revealed to be on active CPAP will be encouraged to continue CPAP for an additional 12?weeks; participants who had been on sham devices will be encouraged to have a repeat CPAP titration study and to crossover to active CPAP treatment for 24?weeks. An intention-to-treat approach will be used for efficacy analyses. The trial is registered with Clinicaltrials.gov (NCT01901055).

SUBMITTER: Chasens ER

PROVIDER: S-EPMC6311443 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Diabetes sleep treatment trial: Premise, design, and methodology.

Chasens Eileen R ER Atwood Charles W CW Burke Lora E LE Korytkowski Mary M Stansbury Robert R Strollo Patrick J PJ Sereika Susan M SM

Contemporary clinical trials 20181202

The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to descri ...[more]

PMID: 30517889

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Project description:ObjectiveWe report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) with findings of extracranial venous anomalies, considered hallmarks of chronic cerebrospinal venous insufficiency (CCSVI), in a 2-phase study (ClinicalTrials.gov NCT01450072).MethodsPhase 1 was an open-label safety study (10 patients); phase 2 was sham-controlled, randomized, and double-blind (10 sham procedure, 9 treated). All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI. Assessment was at 1, 3, and 6 months postprocedure with MRI, clinical, and hemodynamic outcomes. Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life.ResultsNo perioperative complications were noted; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as nonsignificant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow-up. No differences in other endpoints were detected.ConclusionVenous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity.Classification of evidenceThis is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure.

Project description:People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013.

Project description:BackgroundHispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. Interdisciplinary interventions which target Hispanic women and their 3-5-year old children to improve nutrition and physical activity behaviors, manage adiposity and weight in mothers, and prevent excessive adiposity and weight gain trajectory in their children offer promise to break the intergenerational cycle.MethodsUsing a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and physical activity program including education, coping skills training, and home-based intervention in Hispanic women and their 3-5-year old children. The program includes 6 months of continued monthly contact to help overweight and obese Hispanic mothers and their children improve adiposity, weight (trajectory for children), health behaviors (nutrition and physical activity), and self-efficacy We will partner with two federally qualified health departments in Durham and Chatham counties, North Carolina to enroll participants. We will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI ≥ 25 kg/m2 and 294 Hispanic 3-5-year old children with a ≥ 25th BMI percentile will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity and weight in mothers and children (primary outcomes). Secondary outcomes will include health behaviors and self-efficacy in the mothers and in the children. We will also evaluate the cost of delivering the program for public health departments. We will use general linear mixed models to test the hypotheses.DiscussionDecreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs.Trial registrationNCT03866902. (March 7, 2019).

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Diabetes sleep treatment trial: Premise, design, and methodology.

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Diabetes sleep treatment trial: Premise, design, and methodology.

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