Diabetes Mellitus, Type 2NCT04024631
Phenotyping Genetic Risk for Type 2 Diabetes
A study testing 75g glucose beverage (Glucola, Trutol, or similar brand) and DXA, whole body in people with Diabetes Mellitus, Type 2 and Genetics, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Genetics
- What is being tested?
- 75g glucose beverage (Glucola, Trutol, or similar brand) and DXA, whole body
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 10-70 years
- Prior participant of the UPenn Biobank or Center for Applied Genomics Biobank and agreed to be recontacted for future research.
- Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher
Who cannot join
- prior diagnosis of type 1, type 2, or secondary diabetes
- use of medications that would impact glucose and insulin response such as steroids, metformin or other anti-diabetic medication
- acute illness that may impact insulin and glucose dynamics
- pregnancy
- hypothalamic obesity or related genetic disorder of metabolism
- recent systemic chemotherapy use
Show all 10Show fewer
- gastrointestinal impairment or surgery that may impact absorption
- anemia
- major organ system illness or any underlying condition requiring regular medication or treatment that could make implementation of the protocol or interpretation of the study results difficult
- inability to comply with study protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Esther Oyerinde contact
United States2 sites, 2 recruiting
- Not yet recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jessica R Wilson, MD, MS, 215 898-3389, jessica.wilson3@uphs.upenn.edu
Esther Oyerinde, esther.oyerinde@pennmedicine.upenn.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica R Wilson, MD, MS, 215 898-3389, jessica.wilson3@uphs.upenn.edu
Esther Oyerinde, esther.oyerinde@pennmedicine.upenn.edu
About this study
Official title: Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.
Read the detailed description
The study team will recruit individuals based on genetic risk score for type 2 diabetes from the biobank populations who have agreed to be recontacted for future research. Each participant will undergo a frequently sampled four-hour oral glucose tolerance test and whole body DXA scan (dual-energy X-ray absorptiometry) in addition to baseline laboratory and history assessment.
- Conditions
- Diabetes Mellitus, Type 2, Genetics
- Being tested
- 75g glucose beverage (Glucola, Trutol, or similar brand), DXA, whole body
- Keywords
- polygenic risk for type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75g glucose beverage (Glucola, Trutol, or similar brand)Other
Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test.
DXA, whole bodyOther
Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.
| Study group | Role | What they receive |
|---|---|---|
| Phenotyping | Other | All participants will undergo a four-hour frequently sampled oral glucose tolerance test in which they will ingest a 75g glucose beverage (intervention) within five minutes and have samples collected at baseline and for four hours after.
They will also undergo a whole body DXA (intervention) during the study day. Receives: Other: 75g glucose beverage (Glucola, Trutol, or similar brand); Other: DXA, whole body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response to an oral glucose load
Glucose area under the curve after the 75g glucose beverage
Measured: samples will be collected over four hours and these results will be used to calculate area under the curve
Secondary outcomes (3)
Visceral adiposity index
DXA whole body scan visceral adiposity index
Measured: DXA scan will be obtained on the same day as the oral glucose test and will be completed in less than 30 minutes
HOMA-IR
Insulin resistance estimate
Measured: calculated from baseline fasting insulin and glucose levels
Disposition index
product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques
Measured: samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Jun 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cross sectional
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica R.Wilson, MD, MS, University of Pennsylvania
- Investigators
- Jessica R Wilson, MD, MS, Principal investigator, University of PennsylvaniaLorraine Levitt Katz, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024631
- Sponsor's protocol ID
- 831865
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2019
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04024631
- Acronym / sponsor ID
- 831865
- Conditions
- Diabetes Mellitus, Type 2, Genetics
- Keywords
- polygenic risk for type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jul 2019 (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.
This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.
Detailed description
The study team will recruit individuals based on genetic risk score for type 2 diabetes from the biobank populations who have agreed to be recontacted for future research. Each participant will undergo a frequently sampled four-hour oral glucose tolerance test and whole body DXA scan (dual-energy X-ray absorptiometry) in addition to baseline laboratory and history assessment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cross sectional
| Arm | Type | Receives |
|---|---|---|
| Phenotyping | Other | Other: 75g glucose beverage (Glucola, Trutol, or similar brand), Other: DXA, whole bodyAll participants will undergo a four-hour frequently sampled oral glucose tolerance test in which they will ingest a 75g glucose beverage (intervention) within five minutes and have samples collected at baseline and for four hours after. They will also undergo a whole body DXA (intervention) during the study day. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 10-70 years
- Prior participant of the UPenn Biobank or Center for Applied Genomics Biobank and agreed to be recontacted for future research.
- Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher
Key exclusion criteria (10 listed)
- prior diagnosis of type 1, type 2, or secondary diabetes
- use of medications that would impact glucose and insulin response such as steroids, metformin or other anti-diabetic medication
- acute illness that may impact insulin and glucose dynamics
- pregnancy
- hypothalamic obesity or related genetic disorder of metabolism
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 |
|---|---|---|
| 75g glucose beverage (Glucola, Trutol, or similar brand)Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test. | Other | Phenotyping |
| DXA, whole bodySubjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution. | Other | Phenotyping |
Primary outcome
Glucose response to an oral glucose load
Time frame: samples will be collected over four hours and these results will be used to calculate area under the curve
Glucose area under the curve after the 75g glucose beverage
3 secondary outcomes
Visceral adiposity index
Time frame: DXA scan will be obtained on the same day as the oral glucose test and will be completed in less than 30 minutes
HOMA-IR
Time frame: calculated from baseline fasting insulin and glucose levels
Disposition index
Time frame: samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
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.
Esther Oyerinde contact
Jessica R Wilson, MD, MS principal investigator
University of Pennsylvania
Lorraine Levitt Katz, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 75g glucose beverage (Glucola, Trutol, or similar brand) and DXA, whole body in people with Diabetes Mellitus, Type 2 and Genetics, run by University of Pennsylvania at 2 sites 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 10 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica R Wilson, MD, MS (215 898-3389, jessica.wilson3@uphs.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose response to an oral glucose load (time frame: samples will be collected over four hours and these results will be used to calculate area under the curve). 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 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.