ST-ONGE M-P
Lifestyle Patterns and Glycemic Control
NCT05224986 https://clinicaltrials.gov/ct2/show/NCT05224986
Variability in lifestyle behaviors has been associated with adverse health, specifically poor glucose control. 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.
lsb2173@cumc.columbia.edu
&Energy Balance
NCT03663530 https://clinicaltrials.gov/ct2/show/NCT03663530
Preliminary findings from our lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.
Contact: Hedda Boege hlb2156@cumc.columbia.edu
SHECHTER A
Poor Sleep, Sedentary Behavior, and Secondary Cardiovascular Risk in Stroke and TIA Patients
NIH/NHLBI; R01HL141494. PI: Shechter
Effect of CPAP on Diet, Physical Activity, and Cardiovascular Risk
NCT01944020 https://clinicaltrials.gov/ct2/show/NCT01944020
Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep (SWS). The current proposal will investigate the effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with moderate-to-severe OSA and EDS.
Re-Engineering Precision Therapeutics Through N-of-1 Trials
NIH/NLM; R01LM012836. PI: Davidson; Role: Co-I
Contact: Ari Shechter, PhD (212) 851-5584 as4874@columbia.edu
MCGLINCHEY E
Study of Adolescents with Depression & Sleep Disturbances
NCT02429674 https://clinicaltrials.gov/ct2/show/NCT02429674
We are conducting research to compare different ways of improving sleep and mood in teens. Treatment involves Behavioral Sleep Therapy and Interpersonal Psychotherapy for Adolescents targeting: depression trouble falling and staying asleep not feeling rested on waking feeling sleepy during the day.
Contact: Ellie McGlinchey PhD (646) 774-5859 ellie.mcglinchey@nyspi.columbia.edu
SHUFFREY LC
Effects of Maternal Diabetes on Perinatal Neurophysiology and Infant Development.
Funded by the The Rita G. Rudel Foundation.
In our ongoing study in the Columbia University Medical Center Nursery, we are investigating the effects of maternal metabolic dysregulation on neonatal electrocortical function during natural sleep and subsequent infant development.
Vascular Endothelial Activation in Sleep Apnea
NCT03122639 https://clinicaltrials.gov/ct2/show/NCT03122639
The goals of this project are: 1) To determine whether reduced complement inhibition promotes endothelial dysfunction in OSA and whether CPAP reverses these changes, 2) To determine whether reduced complement inhibition is mediated by cholesterol accumulation in ECs in OSA and whether CPAP reverses these changes, and 3) To determine whether statins prevent endothelial dysfunction in OSA by preserving complement inhibition using randomized design. Using an innovative approach to characterize human vascular endothelium, the proposed studies may advance our understanding of vascular dysfunction in OSA and provide the basis for clinical trials of novel therapeutic strategies, such as addition of statins to the standard CPAP therapy, for preventing and/or reversing vascular risk in OSA.
Contact: Sanja Jelic, MD (212) 543-8875 sj366@cumc.columbia.edu
PI-SUNYER F. X
Look AHEAD: Action for Health in Diabetes (LookAHEAD)
NCT00017953 https://clinicaltrials.gov/ct2/show/NCT00017953
The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
Diabetes Prevention Program Outcomes Study (DPPOS)
NCT00038727 https://clinicaltrials.gov/ct2/show/NCT00038727
The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
LIFT: Lifestyle Interventions For Two (LIFT)
NCT01616147 https://clinicaltrials.gov/ct2/show/NCT01616147
This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help participants achieve and maintain changes in dietary intake and physical activity habits compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. The hypothesis is that the percent body fat at birth will be significantly less in offspring from ILI mothers than UC mothers.