Endothelial Function in Obese Adolescents

NCT01879033 | Completed

• 1 other identifier: 09-07-219E
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; endothelial function; Rh-PAT; adipocytokines

Outcome Measures

Primary Outcomes (1)

• RH-Pat score

  After Screening visit, the subjects were assessed for endothelial function using Rh-PAT.

  2 weeks after Screening Visit

Secondary Outcomes (4)

• insulin levels

  Visit 1 (two(2) weeks after Screening Visit)

• Lipid Profile

  Visit 1 (two(2) weeks after Screening Visit)

• Adipocytokine levels

  Visit 1 (two(2) weeks after Screening Visit)

• Glucose levels

  Visit 1 (two(2) weeks after Screening Visit)

Study Arms (2)

Obese adolescents

ACTIVE COMPARATOR

Those with BMI more than or equal to 95th percentile. This group was further divided into two subgroups on the basis of Oral Glucose Tolerance Test (OGTT) into normal and impaired glucose tolerance groups. Reactive hyperemia peripheral artery tonometry (Rh-PAT)score and blood levels for glucose, insulin, lipids and adipocytokines will be measured in the study.

Other: Reactive hyperemia peripheral artery tonometry (Rh-PAT); Other: Blood levels for glucose, insulin, lipids and adipocytokines

Lean adolescents

PLACEBO COMPARATOR

BMI between 5th-85th percentile.Reactive hyperemia peripheral artery tonometry (Rh-PAT)score and blood levels of glucose, insulin, lipids and adipocytokines will be measured in the study.

Other: Reactive hyperemia peripheral artery tonometry (Rh-PAT); Other: Blood levels for glucose, insulin, lipids and adipocytokines

Interventions

Reactive hyperemia peripheral artery tonometry (Rh-PAT) OTHER

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.

Also known as: Endopat

Lean adolescents; Obese adolescents

Blood levels for glucose, insulin, lipids and adipocytokines OTHER

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)

Lean adolescents; Obese adolescents

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children in the age range of 12-18 years
• For the lean group, age and sex matched subjects with BMI between 5th-85th percentiles
• Obese group defined as BMI ≥95th percentile. These will further be subgrouped into those with normal and those with abnormal glucose tolerance normal glucose tolerance (NGT) defined as fasting glucose level\<100mg/dl and a 2 hour postprandial glucose level\<140mg/d and abnormal OGTT defined as fasting level ≥100mg/dl and/or 2hr ≥140 using a glucose load of 1.75 g/kg body weight (max 75 g).Hence, we will

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Albert Einstein College of Medicine West Campus Clinical Research Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Agarwal C, Cohen HW, Muzumdar RH, Heptulla RA, Renukuntla VS, Crandall J. Obesity, hyperglycemia and endothelial function in inner city Bronx adolescents: a cross-sectional study. Int J Pediatr Endocrinol. 2013 Oct 29;2013(1):18. doi: 10.1186/1687-9856-2013-18.

  PMID: 24164965 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Obesity; Atherosclerosis

Interventions

Glucose; Insulin; Lipids; Adipokines

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Chhavi Agarwal, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 17, 2013
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (1)