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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 10 and 70 years old.
Select...
My BMI is 25 or higher as an adult, or in the 85th percentile or higher as a child/adolescent.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose response to an oral glucose load
Secondary outcome measures
Disposition index
HOMA-IR
Visceral adiposity index
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,988 Total Patients Enrolled
Jessica R Wilson, MD, MSPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
20 Total Patients Enrolled
Lorraine Levitt Katz, MDPrincipal InvestigatorChildrens Hospital of Philadelphia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently undergone chemotherapy.I am between 10 and 70 years old.You have been part of a specific biobank in the past and agreed to be contacted for future research.My BMI is 25 or higher as an adult, or in the 85th percentile or higher as a child/adolescent.I have had stomach or intestine problems or surgery affecting how I absorb medicine.I have been diagnosed with diabetes.I am not taking medications that affect blood sugar, like steroids or metformin.I have anemia.I have a genetic disorder affecting my metabolism or hypothalamic obesity.I have a current illness affecting my blood sugar and insulin levels.I do not have any major illnesses that could interfere with the study.You have been part of a specific biobank study at UPenn or the Center for Applied Genomics and agreed to be contacted for more research.
Research Study Groups:
This trial has the following groups:- Group 1: Phenotyping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are engaging with this research endeavor?
"Affirmative. According to data published on clinicaltrials.gov, this research is actively seeking volunteers. The study was first posted in June of 2019 and last updated at the end of 2021. A total of 100 participants are required for the trial's two sites."
Answered by AI
May I become a participant in this experiment?
"This trial is recruiting 100 individuals aged between 10 and 70 years old who are diagnosed with type 2 diabetes mellitus. Moreover, these participants must have a BMI of either 25kg/m2 or higher (adults) or 85th percentile or greater (children and adolescents). Additionally, eligible candidates must be previously registered for the UPenn Biobank or Center for Applied Genomics Biobank programs."
Answered by AI
Does this research program permit those over 20 years of age to sign up?
"This research is recruiting those that are at least a decade old and under 70 years of age."
Answered by AI
Are recruitment drives for this trial still active?
"This medical trial is currently enrolling patients as indicated on clinicaltrials.gov. It was initially shared on June 17th 2019 and has most recently been amended on December 30th 2021."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
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