HealthyNCT01312051
Childhood Metabolic Markers of Adult Morbidity in Blacks
An observational study of Healthy and Normal Weight, run by University of Pittsburgh at 1 site in United States.
Trial summary
Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. A common pathogenetic link among these entities is insulin resistance/hyperinsulinemia. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Normal Weight, Overweight
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to 20 Sep 2011
- Phase
- Observational
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy black and white volunteers who are 8 to 17 years of age
Who may be able to join
- Protocols 1 \& 4:
- Age 11-17 years
- Male or Female
- Healthy
- Obese, BMI ≥ 95 percentile
- Pubertal/Tanner Stage II-V
Show all 21Show fewer
- African American or White American, based on self identity with no admixture for 3 generations
- Protocol 2:
- Age 11-17 years
- Male or Female
- Healthy
- Normal Weight, BMI 10- 95 percentile
- Pubertal/Tanner Stage II-V
- African American or White American, based on self-identity with no admixture for 3 generations
- Protocol 3:
- Age 8-12 years
- Male or Female
- Healthy
- Normal Weight, BMI 10-95 percentile
- Prepubertal/Tanner Stage I
- African American or White American, based on self-identity with no admixture for 3 generations
Who cannot join
- Medications which interfere with metabolism
- Hemocue < 12 gm/dl in pubertal subjects and <11gm/dl in prepubertal subjects
- Positive serum pregnancy test
- Recent significant weight change or dieting
- Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. A common pathogenetic link among these entities is insulin resistance/hyperinsulinemia.
The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid (FFA) - induced insulin resistance is associated with larger increases in intramyocellular lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic effect of FFA compared with whites. The methods to be used are: the well- established CT method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL; intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for body composition assessments.
- Conditions
- Healthy, Normal Weight, Overweight
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Protocol 1 | Healthy, overweight 11 to 17 year old black and white adolescents | |
| Protocol 2 | Healthy, normal-weight 11 to 17 year old black and white adolescents | |
| Protocol 3 | Healthy, normal-weight 8 to 12 year old black and white adolescents | |
| Protocol 4 | Healthy, overweight 11 to 17 year old black and white adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle lipid content, insulin sensitivity and insulin secretion
Measured: Assessments at 2 timepoints occur within a 2 to 3 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJul 2004
- Primary completion20 Sep 2011
- Study completion20 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Silva Arslanian, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312051
- Sponsor's protocol ID
- R01HD027503
- Status last verified
- Oct 2017
- First submitted
- 9 Mar 2011
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Metabolic Markers of Adult Morbidity in Blacks
- ClinicalTrials.gov ID
- NCT01312051
- Acronym / sponsor ID
- R01HD027503
- Conditions
- Healthy, Normal Weight, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- 20 Sep 2011 (actual)
- Study completion
- 20 Sep 2011 (actual)
- First posted
- 10 Mar 2011 (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.
Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. A common pathogenetic link among these entities is insulin resistance/hyperinsulinemia.
The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid (FFA) - induced insulin resistance is associated with larger increases in intramyocellular lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic effect of FFA compared with whites. The methods to be used are: the well- established CT method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL; intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for body composition assessments.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protocol 1 | – | –Healthy, overweight 11 to 17 year old black and white adolescents |
| Protocol 2 | – | –Healthy, normal-weight 11 to 17 year old black and white adolescents |
| Protocol 3 | – | –Healthy, normal-weight 8 to 12 year old black and white adolescents |
| Protocol 4 | – | –Healthy, overweight 11 to 17 year old black and white adolescents |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy black and white volunteers who are 8 to 17 years of age
Key inclusion criteria (21 listed)
- Age 11-17 years
- Male or Female
- Healthy
- Obese, BMI ≥ 95 percentile
- Pubertal/Tanner Stage II-V
Key exclusion criteria (5 listed)
- Medications which interfere with metabolism
- Hemocue < 12 gm/dl in pubertal subjects and <11gm/dl in prepubertal subjects
- Positive serum pregnancy test
- Recent significant weight change or dieting
- Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal muscle lipid content, insulin sensitivity and insulin secretion
Time frame: Assessments at 2 timepoints occur within a 2 to 3 week period
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 18 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Normal Weight, run by University of Pittsburgh 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 21 inclusion and 5 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 18 Oct 2017. 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. 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?
Skeletal muscle lipid content, insulin sensitivity and insulin secretion (time frame: Assessments at 2 timepoints occur within a 2 to 3 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2017.