Endothelial Function in Obese Adolescents
NCT01879033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-01-22
Summary
Childhood obesity is perhaps the most significant public health problem in the most developed countries and is rapidly becoming so in developing countries. National Health and Nutrition Examination Survey data shows a 3-fold increase in the prevalence of obesity in childhood, over past few decades. Furthermore, childhood obesity has markedly contributed to the prevalence of the metabolic syndrome and type 2 diabetes in U.S. children. Alarmingly, there is increasing evidence that atherosclerosis develops silently during childhood in obese children. In the Bogalusa Heart Study, pediatric autopsy studies showed a clear relationship between the number and severity of risk factors, principally obesity, with atherosclerosis in both the aorta and coronary arteries. Increased intimal medial thickness (IMT) was not present among obese adults who had been normal weight as children, emphasizing the cumulative effects of childhood obesity persisting into adulthood. Thus, the need for primary prevention of cardiovascular disease beginning in childhood is strongly suggested.
Conditions
- Insulin Resistance
- Glucose Intolerance
- Obesity
- Atherosclerosis
Interventions
- OTHER
-
Reactive hyperemia peripheral artery tonometry (Rh-PAT)
Pulse volume is measured by a finger plethysmographic device which are sensed by a pressure transducer and transferred to a computer where the signal is amplified, displayed and stored (EndoPAT, Itamar Medical). Fingertip probes are placed on the index finger of both hands and 5 minutes of baseline recording are obtained. Blood flow is then occluded in one arm for 5 minutes, using a standard blood pressure cuff. Recording continues in both fingers during occlusion and for 5 minutes after release of the cuff. The RH-PAT index is calculated as the ratio of the average pulse amplitude in the post-hyperemic phase divided by the average baseline amplitude, with normalization to the signal in the control arm to compensate for any systemic changes.
- OTHER
-
Blood levels for glucose, insulin, lipids and adipocytokines
A fasting laboratory evaluation will include chemistry panel (basic metabolic, liver function tests), CBC, lipid profile, urinalysis and HbA1c. All obese recruited subjects after a 12 hour fast will undergo an OGTT using a glucose load of 1.75 g/kg body weight with a maximum of 75 g. Blood samples will be collected for insulin, glucose, leptin, adiponectin, hsCRP and FFA. Serum and urine will be stored at -70 degrees Centigrade for measuring markers of oxidative stress and adipocytokines (including TNF-α, PAI-1)
Sponsors & Collaborators
-
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Chhavi Agarwal, MD · Montefiore Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2013-06-30
- Completion
- 2014-01-31
Countries
- United States
Study Locations
More Related Trials
-
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
NCT05065372 ·Status: RECRUITING ·Phase: PHASE1
-
Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes
NCT01021865 ·Status: COMPLETED
-
Metformin to Treat Obesity in Children With Insulin Resistance
NCT00005669 ·Status: COMPLETED ·Phase: PHASE2
-
Modulation of Human Myocardial Metabolism by GLP-1 Dose Response
NCT01607450 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Novel Type 2 Diabetes Mellitus Preventive Therapies
NCT02351323 ·Status: COMPLETED ·Phase: PHASE1
-
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease
NCT05067621 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
NCT02960659 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment
NCT04177303 ·Status: UNKNOWN ·Phase: PHASE3
-
Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes
NCT03620773 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Endothelial and Metabolic Effects of Glucagon-like Peptide-1 (GLP-1) in Coronary Circulation in Patients With Type 2 Diabetes Mellitus
NCT00923962 ·Status: COMPLETED ·Phase: NA
-
Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults
NCT01419535 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village
NCT01535105 ·Status: UNKNOWN
-
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
NCT05414409 ·Status: RECRUITING ·Phase: PHASE2
-
The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM).
NCT00361946 ·Status: COMPLETED
-
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
NCT03269747 ·Status: COMPLETED ·Phase: PHASE4
-
Role of the Liver in Glucose Homeostasis Using Metabolic Imaging
NCT04352738 ·Status: COMPLETED
-
Acute Changes in Plasma Glucose and Cardiovascular Disease in Diabetes
NCT05500352 ·Status: UNKNOWN ·Phase: NA
-
The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults
NCT00845559 ·Status: WITHDRAWN ·Phase: PHASE4
-
Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes
NCT05119179 ·Status: RECRUITING ·Phase: PHASE4
-
GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
NCT04387201 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
NCT00846521 ·Status: TERMINATED ·Phase: PHASE4
-
GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations
NCT02082496 ·Status: COMPLETED ·Phase: PHASE2
-
Human Vasodilatory Effect of GLP-1
NCT03502083 ·Status: COMPLETED ·Phase: NA
-
Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers
NCT03835013 ·Status: COMPLETED ·Phase: NA
-
Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY)
NCT07029009 ·Status: RECRUITING ·Phase: PHASE2