Metabolomic Profiling in Adolescents With Obesity and Diabetes

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.

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Key information

Conditions

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

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Time frame: 2 years

Other outcomes

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

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

American Diabetes Association

Registry information

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2020
First posted: May 23, 2014
Registry last updated: Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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