- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879033
Endothelial Function in Obese Adolescents
Effect Of Obesity And Hyperglycemia on Endothelial Function in Inner City Bronx Adolescents
Study Overview
Status
Detailed Description
Following informed consent, a detailed history and physical examination will be performed including supine blood pressure taken twice after a 20 minute period of rest, height (using Harpenden stadiometer) to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg with a balance scale, pubertal staging using the method of Marshall and Tanner, waist measurement obtained at the minimal circumference of the abdomen, hip measurements with a plastic tape while the subject is standing and recorded at the widest diameter over the greater trochanters. BMI (kg/m2) and waist to hip ratio will be calculated. Screening labs in all recruited subjects: A fasting laboratory evaluation will include chemistry panel (basic metabolic, liver function tests), Complete Blood Count (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, High sensitive C-reactive protein (hsCRP) and Free Fatty Acids (FFA). Serum and urine will be stored at -70 (degree Centigrade)C for measuring markers of oxidative stress and adipocytokines (including Tumor Necrosis Factor (TNF)-α, Plasminogen Acivator Inhibitor (PAI)-1) for future studies depending on the funding availability.
Subjects who fulfill the study criteria would be admitted to Clinical Research Center to evaluate endothelial function by RH-PAT.
RH-PAT for endothelial function Reactive hyperemia peripheral arterial tonometry (RH-PAT) is a noninvasive technique used to assess peripheral microvascular endothelial function by measuring changes in digital pulse volume during reactive hyperemia (Bonetti, Kuvin). Pulse volume is measured by a finger plethysmographic device that allows isolated detection of pulsatile arterial volume changes, which are sensed by a pressure transducer and transferred to a computer where the signal is amplified, displayed and stored (EndoPAT, Itamar Medical). Studies are performed with the patient at rest, in a comfortable, thermo neutral environment. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Albert Einstein College of Medicine West Campus Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Obese adolescents
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.
|
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 Names:
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)
|
Placebo Comparator: Lean adolescents
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.
|
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 Names:
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RH-Pat score
Time Frame: 2 weeks after Screening Visit
|
After Screening visit, the subjects were assessed for endothelial function using Rh-PAT.
|
2 weeks after Screening Visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insulin levels
Time Frame: Visit 1 (two(2) weeks after Screening Visit)
|
Subjects were assesses for insulin level on Visit 1. Lean subjects only had fasting levels of insulin, while obese had 2 hour Oral glucose tolerance test.
|
Visit 1 (two(2) weeks after Screening Visit)
|
Lipid Profile
Time Frame: Visit 1 (two(2) weeks after Screening Visit)
|
Subjects were assessed for fasting cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL) and Triglyceride levels during the visit 1.
|
Visit 1 (two(2) weeks after Screening Visit)
|
Adipocytokine levels
Time Frame: Visit 1 (two(2) weeks after Screening Visit)
|
Subjects were assessed for levels of adipocytokines which include Leptin, Adiponectin, Tumor Necrosis Factor (TNF)- alfa, Interleukin (IL)-6 during the Visit 1.
|
Visit 1 (two(2) weeks after Screening Visit)
|
Glucose levels
Time Frame: Visit 1 (two(2) weeks after Screening Visit)
|
Subjects were assesses for glucose levels on Visit 1. Lean subjects only had fasting levels of glucose, while obese had 2 hour Oral glucose tolerance test.
|
Visit 1 (two(2) weeks after Screening Visit)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chhavi Agarwal, MD, Montefiore Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Hyperinsulinism
- Hyperglycemia
- Obesity
- Glucose Intolerance
- Insulin Resistance
- Atherosclerosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
Other Study ID Numbers
- 09-07-219E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Reactive hyperemia peripheral artery tonometry (Rh-PAT)
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedPostural Tachycardia Syndrome (POTS)United States
-
University of MonastirEnrolling by invitation
-
Mayo ClinicTerminatedHeart FailureUnited States
-
Cedars-Sinai Medical CenterActive, not recruitingMicrovascular Coronary DysfunctionUnited States
-
Algemeen Ziekenhuis Maria MiddelaresRecruitingCancer | Atherosclerosis | Cardiotoxicity | Diastolic Dysfunction | Immune Checkpoint Inhibitor-Related Myocarditis | Immune-related Adverse Event | Cardiac Abnormalities, VariableBelgium
-
University Hospital, GenevaStanislas Abrard; Noble StéphaneNot yet recruitingAortic Valve Stenosis
-
Massachusetts General HospitalSpina, Stefano, M.D., Massachusetts General Hospital; Marrazzo, Francesco,... and other collaboratorsRecruitingCardiovascular Diseases | Endothelial Dysfunction | Cardiovascular Risk Factor | Hemolysis IntravascularUnited States