Metabolomic Profiling in Adolescents With Obesity and Diabetes

NCT02145572 | Completed

• 1 other identifier: UCSD-IRB-140054
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children. We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.

Conditions

Metabolomics; Obesity; Diabetes; Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls.

  2 years

Other Outcomes (1)

• Validation of presence of DENND1A isoform in the urine of adolescent females with polycystic ovarian syndrome

  2 years

Study Arms (3)

Obese adolescents with type 2 diabetes

No intervention

Obese adolescents without diabetes

No intervention

Healthy non-obese adolescents

No intervention

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical practices affiliated with Rady Children's Hospital.

You may qualify if:

• Age of 13-19 years
• Gender: male and female
• Ethnic background: any
• Obesity will be defined as BMI \>95th percentile for age/gender
• Diagnosis of diabetes will be defined by current American Diabetes Association criteria
• Diabetes duration \< 2.5 years
• Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody)
• Adult caregiver willing to actively support study participation
• Signed parental informed consent form and adolescent assent form

You may not qualify if:

• Creatinine clearance \<60 mL/min (calculated from estimated GFR)
• Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation.
• For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment

Sponsors & Collaborators

• University of California, San Diego: lead
• American Diabetes Association: collaborator

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Jane J Kim, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Department of Pediatrics

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 23, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

US (1)