PreDiabetesNCT05055219
Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
An observational study of PreDiabetes and Obesity, Childhood, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and… Read more about this study
- Who is it for?
- Ages 8 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity, Childhood
- Type of treatment
- Pill or oral medicine
- How many people
- 772 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 19 Feb 2020
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will consist of normal weight, overweight or obese individuals aged 8 to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and #4. Participants will be recruited from a variety of sites including University Michigan clinical sites, non-University of Michigan clinical sites, schools in the local area, and the University Michigan medical school campus. Participants from Group 2 (visits #3-4) completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes.
Who may be able to join
- Groups 1 and 2 (overweight and obese groups):
- Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
- Overweight or obese, as defined by a BMI ≥ 85th% \& <95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and <30 and BMI ≥30
- For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
- Group 3 (Normal weight controls):
- Age 8-17 years
- Healthy weight, as defined by a BMI ≥ 5th percentile \& < 85th percentile, respectively by age and sex
Who cannot join
- Previous diagnosis of type 1 diabetes
- Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
- Verbal report of Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.
- Conditions
- PreDiabetes, Obesity, Childhood
- Medical subject headings
- Prediabetic State, Pediatric Obesity
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 |
|---|---|---|
| Group 1: Overweight or Obese Group (visits #1-4) | Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight. Overweight or obese, as defined by a BMI ≥ 85th percentile \& <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. | |
| Group 2: Overweight or Obese Group (visits #3-4) | Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight, or children and young adults who previously participated in the study (completed visits #1-2 in previous study phase). Overweight or obese, as defined by a BMI ≥ 85th percentile \& <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. | |
| Group 3: Normal Weight Control Group | Children and adolescents who are 8 to 17 years of age, who have do not have risk factors for diabetes such as being overweight or a history of type 2 diabetes in the family. Healthy weight, as defined by a BMI ≥ 5th percentile \& < 85th percentile. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of glucose tolerance
Normal glucose tolerance, prediabetes, or diabetes
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startJun 2015
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Cross-sectional
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Joyce Lee, University of Michigan
- Investigators
- Joyce Lee, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055219
- Sponsor's protocol ID
- HUM00006955
- Other IDs
- 5R01HD074559-05
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
- ClinicalTrials.gov ID
- NCT05055219
- Acronym / sponsor ID
- HUM00006955
- Conditions
- PreDiabetes, Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2015 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 24 Sep 2021 (actual)
- 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 evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Overweight or Obese Group (visits #1-4) | – | –Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight. Overweight or obese, as defined by a BMI ≥ 85th percentile \& <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. |
| Group 2: Overweight or Obese Group (visits #3-4) | – | –Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight, or children and young adults who previously participated in the study (completed visits #1-2 in previous study phase). Overweight or obese, as defined by a BMI ≥ 85th percentile \& <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. |
| Group 3: Normal Weight Control Group | – | –Children and adolescents who are 8 to 17 years of age, who have do not have risk factors for diabetes such as being overweight or a history of type 2 diabetes in the family. Healthy weight, as defined by a BMI ≥ 5th percentile \& < 85th percentile. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. |
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of normal weight, overweight or obese individuals aged 8 to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and #4. Participants will be recruited from a variety of sites including University Michigan clinical sites, non-University of Michigan clinical sites, schools in the local area, and the University Michigan medical school campus. Participants from Group 2 (visits #3-4) completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes.
Key inclusion criteria (7 listed)
- Groups 1 and 2 (overweight and obese groups):
- Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
- Overweight or obese, as defined by a BMI ≥ 85th% \& <95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and <30 and BMI ≥30
- For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
- Group 3 (Normal weight controls):
Key exclusion criteria (3 listed)
- Previous diagnosis of type 1 diabetes
- Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
- Verbal report of Pregnancy
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
Progression of glucose tolerance
Time frame: Up to 5 years
Normal glucose tolerance, prediabetes, or diabetes
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 24 Sep 2021.
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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.
Joyce Lee, MD, MPH principal investigator
University of Michigan
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 PreDiabetes and Obesity, Childhood, run by University of Michigan 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 7 inclusion and 3 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 24 Sep 2021. 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?
Progression of glucose tolerance (time frame: Up to 5 years). 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 24 Sep 2021.