Novel Biomarker for Development of T2D
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|ClinicalTrials.gov Identifier: NCT02326129|
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : December 25, 2018
|Condition or disease|
|Diabetes Type II|
The overarching hypothesis is that increases in whole body 11β-HSD1 activity precede and presage the development of type 2 diabetes (T2D) in high-risk obese adolescents, serving as a critical determinant of insulin resistance and glucose intolerance. The increase in 11β-HSD1 activity, in combination with decreases in 5α-reductase activity, will increase tissue cortisol production, promoting the development of insulin resistance and the metabolic syndrome and predisposing to T2D. The investigators predict that increases in 11β-HSD1 activity will be detected in obese children prior to the development of insulin resistance and glucose intolerance and that the progressive increases in 11β-HSD1 will correlate with progressive decreases in insulin sensitivity and glucose tolerance. Given preliminary findings, the investigators also predict that increases in 11β-HSD1 will be greater and occur earlier in development in males than females. This could establish 11β-HSD1 activity as a novel, non-invasive biomarker for progression to, or for development of, glucose intolerance and T2D.
The identification of 11β-HSD1 as a biomarker that predicts T2D would have critical clinical import, allowing us to identify obese children and adults at highest risk of metabolic decompensation. Studies of 11β-HSD1 in obese subjects with varying degrees of IR and glucose intolerance will also narrow critical gaps in the understanding of the pathogenesis of T2D.
The investigators would like to also validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with insulin resistance. To that end the investigators would like to examine detailed metabolomic profiles in 24 hour and spot urine samples.
The study population will include 50 obese adolescents with T2D, 50 obese adolescents without T2D and 50 age, gender, race and pubertal status-matched normal weight controls. The subjects will be recruited at the Healthy Lifestyle Program at Duke, Diabetes Clinics at Lenox Baker Children's Hospital and Roxboro Clinics.
Study activities include physical exam and medical history, vitals, laboratory tests (only for obese adolescents), urine testing for sugar (only for normal weight adolescents), 24 hour urine collection, spot urine collection, body fat content measurement, and food and activity questionnaire.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||A Novel Biomarker for Development of Type 2 Diabetes: 11Beta-Hydroxy Steroid Dehydrogenase Type 1 Activity|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Obese with Type 2 Diabetes
Obese adolescents with Type 2 Diabetes
Obese without Type 2 Diabetes
Obese adolescents without Type 2 Diabetes
Normal weight adolescents
- Relationship between 11β-HSD1 and 5α-reductase activity, and measures of insulin resistance [ Time Frame: Two year ]To assess the relationship between 11β-HSD1 and 5α-reductase activity, and measures of insulin resistance in a cohort of obese children with varying degrees of insulin resistance and glucose intolerance
- Gender and pubertal status [ Time Frame: Two year ]Investigate the role of gender and pubertal status on 11β-HSD1 and 5α-reductase activity
- Compare 11β-HSD1 activity and 5α-reductase activity among obese adolescents with T2D, obese adolescents without T2D and normal weight controls [ Time Frame: Two year ]The investigators hypothesize that obese adolescents with T2D will have the highest levels of 11β-HSD1 activity followed by the obese adolescents with insulin resistance, followed by obese subjects with normal insulin sensitivity. Normal weight control group will have the lowest levels.
- Relationship between 11β-HSD1 and 5α-reductase activity, and key metabolic signatures associated with insulin resistance [ Time Frame: Two year ]The investigators hypothesize that 11β-HSD1 activity will be positively associated, and 5α-reductase activity negatively associated, with key metabolic signatures associated with insulin resistance.
- Urine metabolic signatures associated with insulin resistance and type 2 diabetes [ Time Frame: Two year ]The investigators would like to validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with insulin resistance
- Spot urine for metabolic profiling [ Time Frame: Two year ]The investigators hypothesize that they will identify the same key metabolomic signatures associated with insulin resistance in obese adolescents with T2D compared to obese adolescents without T2D, and normal weight control group in spot fasting am urine samples.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326129
|Contact: Pinar Gumus Balikcioglu, M.D.||firstname.lastname@example.org|
|Contact: Denise Simmons, BSemail@example.com|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Pinar Gumus Balikcioglu, M.D. 919-668-4002 firstname.lastname@example.org|
|Principal Investigator:||Pinar Gumus Balikcioglu, M.D.||Pediatric Endocrinology|