Insulin ResistanceNCT01879033
Endothelial Function in Obese Adolescents
A study testing Reactive hyperemia peripheral artery tonometry (Rh-PAT) and Blood levels for glucose, insulin, lipids and adipocytokines in people with Insulin Resistance and Glucose Intolerance, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Glucose Intolerance, Obesity
- What is being tested?
- Reactive hyperemia peripheral artery tonometry (Rh-PAT) and Blood levels for glucose, insulin, lipids and adipocytokines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine West Campus Clinical Research Center
The Bronx, New York, 10467
About this study
Official title: Effect Of Obesity And Hyperglycemia on Endothelial Function in Inner City Bronx Adolescents
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.
Read the 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.
- Conditions
- Insulin Resistance, Glucose Intolerance, Obesity, Atherosclerosis
- Being tested
- Reactive hyperemia peripheral artery tonometry (Rh-PAT), Blood levels for glucose, insulin, lipids and adipocytokines
- Keywords
- Obesity, endothelial function, Rh-PAT, adipocytokines
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Obesity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive hyperemia peripheral artery tonometry (Rh-PAT)Other
Also called Endopat
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.
Blood levels for glucose, insulin, lipids and adipocytokinesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Reactive hyperemia peripheral artery tonometry (Rh-PAT); Other: Blood levels for glucose, insulin, lipids and adipocytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
RH-Pat score
After Screening visit, the subjects were assessed for endothelial function using Rh-PAT.
Measured: 2 weeks after Screening Visit
Secondary outcomes (4)
insulin levels
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.
Measured: Visit 1 (two(2) weeks after Screening Visit)
Lipid Profile
Subjects were assessed for fasting cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL) and Triglyceride levels during the visit 1.
Measured: Visit 1 (two(2) weeks after Screening Visit)
Adipocytokine levels
Subjects were assessed for levels of adipocytokines which include Leptin, Adiponectin, Tumor Necrosis Factor (TNF)- alfa, Interleukin (IL)-6 during the Visit 1.
Measured: Visit 1 (two(2) weeks after Screening Visit)
Glucose levels
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.
Measured: Visit 1 (two(2) weeks after Screening Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chhavi Agarwal, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879033
- Sponsor's protocol ID
- 09-07-219E
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2013
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24164965
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Obesity And Hyperglycemia on Endothelial Function in Inner City Bronx Adolescents
- ClinicalTrials.gov ID
- NCT01879033
- Acronym / sponsor ID
- 09-07-219E
- Conditions
- Insulin Resistance, Glucose Intolerance, Obesity, Atherosclerosis
- Keywords
- Obesity, endothelial function, Rh-PAT, adipocytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents | Active comparator | Other: Reactive hyperemia peripheral artery tonometry (Rh-PAT), Other: Blood levels for glucose, insulin, lipids and adipocytokinesThose 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. |
| Lean adolescents | Placebo comparator | Other: Reactive hyperemia peripheral artery tonometry (Rh-PAT), Other: Blood levels for glucose, insulin, lipids and adipocytokinesBMI 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reactive hyperemia peripheral artery tonometry (Rh-PAT)Also: EndopatPulse 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 | Lean adolescents, Obese adolescents |
| Blood levels for glucose, insulin, lipids and adipocytokinesA 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) | Other | Lean adolescents, Obese adolescents |
Primary outcome
RH-Pat score
Time frame: 2 weeks after Screening Visit
After Screening visit, the subjects were assessed for endothelial function using Rh-PAT.
4 secondary outcomes
insulin levels
Time frame: Visit 1 (two(2) weeks after Screening Visit)
Lipid Profile
Time frame: Visit 1 (two(2) weeks after Screening Visit)
Adipocytokine levels
Time frame: Visit 1 (two(2) weeks after Screening Visit)
Glucose levels
Time frame: Visit 1 (two(2) weeks after Screening Visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 24164965Agarwal 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.
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chhavi Agarwal, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive hyperemia peripheral artery tonometry (Rh-PAT) and Blood levels for glucose, insulin, lipids and adipocytokines in people with Insulin Resistance and Glucose Intolerance, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RH-Pat score (time frame: 2 weeks after Screening Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.