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Genetic Testing

Genetic Risk Assessment for Type 2 Diabetes

N/A

Recruiting

Led By Jessica R Wilson, MD, MS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-70 years

Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher

Must not have

Recent systemic chemotherapy use

Prior diagnosis of type 1, type 2, or secondary diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether people with a high genetic risk for type 2 diabetes have worse blood sugar control and are more resistant to insulin than those with a low genetic risk.

Who is the study for?

This trial is for individuals aged 10-70, with adults having a BMI of 25 or higher and children in the 85th percentile for BMI. Participants must have previously joined the UPenn or Center for Applied Genomics Biobank and agreed to future contact. It's not open to those with diabetes, anemia, recent chemotherapy, certain metabolic disorders, on medications affecting glucose/insulin response like steroids or metformin, pregnant women, people with acute illness impacting insulin/glucose dynamics, gastrointestinal issues affecting absorption or major illnesses requiring regular medication.

What is being tested?

The study investigates if non-diabetic individuals at high genetic risk for type 2 diabetes show impaired glucose tolerance and insulin resistance compared to those at low risk. Participants will consume a standard glucose beverage (75g) followed by tests including DXA scans and whole-body assessments.

What are the potential side effects?

While consuming the glucose beverage may cause minimal side effects such as nausea or bloating in some participants; overall this intervention is considered safe with few significant side effects expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 70 years old.

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My BMI is 25 or higher as an adult, or in the 85th percentile or higher as a child/adolescent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently undergone chemotherapy.

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I have been diagnosed with diabetes.

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I am not taking medications that affect blood sugar, like steroids or metformin.

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I have anemia.

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I have a genetic disorder affecting my metabolism or hypothalamic obesity.

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I do not have any major illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ samples will be collected over four hours and these results will be used to calculate area under the curve

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~samples will be collected over four hours and these results will be used to calculate area under the curve

This trial's timeline: 3 weeks for screening, Varies for treatment, and samples will be collected over four hours and these results will be used to calculate area under the curve for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose response to an oral glucose load

Secondary study objectives

Disposition index

HOMA-IR

Visceral adiposity index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PhenotypingExperimental Treatment2 Interventions

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.

0 / 8Eligibility criteria met