Insulin ResistanceNCT00498030
Predicting Insulin Resistance in American Indian Youth
An observational study of Insulin Resistance and Stress, Psychological, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Stress, Psychological
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2005to 29 Mar 2018
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.
Who may be able to join
- Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.
Who cannot join
- Those who have diabetes previously identified or those with chronic steroid use, or identified conditions that affect weight balance such as cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosebud Indian Reservation
Rosebud, South Dakota, 57570
About this study
The purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific positive indicators of insulin resistance are present, individuals are recruited back in one year for repeat of all measures.
Read the detailed description
Type 2 diabetes is rapidly becoming more prevalent in the United States but especially among minority populations at a younger age. Identification of risk factors, including traditional risk factors such as increased BMI, lack of exercise, increased glucose in the diet, higher blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or other drugs has not previously been done with minority youth. If risk factors can be identified, more strategies for prevention of diabetes can be developed that specifically target this population. This study will enroll 300 Native American Youth over a 4 year period and perform body measurements including height, weight, waist circumference, blood pressure and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin creatinine ratio test. In addition, subjects will be asked to identify behavior and feelings of stress in everyday lives. Subjects who are determined to be at increased risk of developing diabetes will be asked to repeat the tests in one year. The results will be reported to the tribal council to help determine prevention strategies.
- Conditions
- Insulin Resistance, Stress, Psychological
- Keywords
- Insulin Resistance, Stress, Psychological
- Medical subject headings
- Insulin Resistance, Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Resistance
This study will assess for change in insulin resistance in Native American Children over one year.
Measured: one year
Secondary outcomes (2)
Changes in Body Mass Index (BMI)
To determine if BMI is a good marker for insulin resistance and if BMI changes after enrollment in diabetes intervention program.
Measured: One year
Change in Fasting Lipids
To determine if fasting lipids levels are a good marker for insulin resistance and if fasting lipid levels change after enrollment in diabetes intervention program.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study start5 Dec 2005
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Health Service (IHS)
- Responsible party
- Sponsor
- Investigators
- Jennifer Larsen, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498030
- Sponsor's protocol ID
- 0453-04-FB
- Other IDs
- U26IHS300002/01
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2007
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nsiah-Kumi PA, Beals J, Lasley S, Whiting M, Brushbreaker C, Erickson J, Qiu F, Yu F, Canaris G, Larsen JL. Body mass index percentile more sensitive than acanthosis nigricans for screening Native American children for diabetes risk. J Natl Med Assoc. 2010 Oct;102(10):944-9. doi: 10.1016/s0027-9684(15)30714-8.
PubMed 21053710Nsiah-Kumi PA, Lasley S, Whiting M, Brushbreaker C, Erickson JM, Qiu F, Yu F, Larsen JL. Diabetes, pre-diabetes and insulin resistance screening in Native American children and youth. Int J Obes (Lond). 2013 Apr;37(4):540-5. doi: 10.1038/ijo.2012.199. Epub 2012 Dec 11.
PubMed 23229738Nsiah-Kumi PA, Erickson JM, Beals JL, Ogle EA, Whiting M, Brushbreaker C, Borgeson CD, Qiu F, Yu F, Larsen JL. Vitamin D insufficiency is associated with diabetes risk in Native American children. Clin Pediatr (Phila). 2012 Feb;51(2):146-53. doi: 10.1177/0009922811417290. Epub 2011 Oct 20.
PubMed 22019791
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Insulin Resistance in American Indian Youth
- ClinicalTrials.gov ID
- NCT00498030
- Acronym / sponsor ID
- 0453-04-FB
- Conditions
- Insulin Resistance, Stress, Psychological
- Keywords
- Insulin Resistance, Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Indian Health Service (IHS)
- Study start
- 5 Dec 2005 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 9 Jul 2007 (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.
The purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific positive indicators of insulin resistance are present, individuals are recruited back in one year for repeat of all measures.
Detailed description
Type 2 diabetes is rapidly becoming more prevalent in the United States but especially among minority populations at a younger age. Identification of risk factors, including traditional risk factors such as increased BMI, lack of exercise, increased glucose in the diet, higher blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or other drugs has not previously been done with minority youth. If risk factors can be identified, more strategies for prevention of diabetes can be developed that specifically target this population. This study will enroll 300 Native American Youth over a 4 year period and perform body measurements including height, weight, waist circumference, blood pressure and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin creatinine ratio test. In addition, subjects will be asked to identify behavior and feelings of stress in everyday lives. Subjects who are determined to be at increased risk of developing diabetes will be asked to repeat the tests in one year. The results will be reported to the tribal council to help determine prevention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.
Key inclusion criteria (1 listed)
- Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.
Key exclusion criteria (1 listed)
- Those who have diabetes previously identified or those with chronic steroid use, or identified conditions that affect weight balance such as cancer.
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
Change in Insulin Resistance
Time frame: one year
This study will assess for change in insulin resistance in Native American Children over one year.
2 secondary outcomes
Changes in Body Mass Index (BMI)
Time frame: One year
Change in Fasting Lipids
Time frame: One year
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 28 Sep 2023.
- Results publication: PubMed 21053710Nsiah-Kumi PA, Beals J, Lasley S, Whiting M, Brushbreaker C, Erickson J, Qiu F, Yu F, Canaris G, Larsen JL. Body mass index percentile more sensitive than acanthosis nigricans for screening Native American children for diabetes risk. J Natl Med Assoc. 2010 Oct;102(10):944-9. doi: 10.1016/s0027-9684(15)30714-8.
- Results publication: PubMed 23229738Nsiah-Kumi PA, Lasley S, Whiting M, Brushbreaker C, Erickson JM, Qiu F, Yu F, Larsen JL. Diabetes, pre-diabetes and insulin resistance screening in Native American children and youth. Int J Obes (Lond). 2013 Apr;37(4):540-5. doi: 10.1038/ijo.2012.199. Epub 2012 Dec 11.
- Results publication: PubMed 22019791Nsiah-Kumi PA, Erickson JM, Beals JL, Ogle EA, Whiting M, Brushbreaker C, Borgeson CD, Qiu F, Yu F, Larsen JL. Vitamin D insufficiency is associated with diabetes risk in Native American children. Clin Pediatr (Phila). 2012 Feb;51(2):146-53. doi: 10.1177/0009922811417290. Epub 2011 Oct 20.
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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.
Jennifer Larsen, MD principal investigator
University of Nebraska
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 Insulin Resistance and Stress, Psychological, run by University of Nebraska 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 1 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 28 Sep 2023. 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?
Change in Insulin Resistance (time frame: one year). 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 NCT00498030, which also lists 3 linked publications.
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 28 Sep 2023.