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Trial record 43 of 87 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
Children's Miracle Network
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The investigators wants to determine if 11β-HSD1 activity will be positively associated, and 5α-reductase activity negatively associated, with (a) degree of insulin resistance defined by the homeostatic model assessment of insulin resistance index (HOMA-IR) and (b) worsening glycemic control defined by higher HbA1c and impaired fasting glucose in a group of obese children and young adults with or without type 2 diabetes compared to lean children and young adults without diabetes. The investigators also want to identify key metabolic signatures associated with diabetes using metabolomic profiling.

Condition or disease
Diabetes Type II

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Obese with Type 2 Diabetes
Obese adolescents with Type 2 Diabetes
Obese without Type 2 Diabetes
Obese adolescents without Type 2 Diabetes
Normal weight
Normal weight adolescents



Primary Outcome Measures :
  1. 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

  2. Gender and pubertal status [ Time Frame: Two year ]
    Investigate the role of gender and pubertal status on 11β-HSD1 and 5α-reductase activity

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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
24 hour urine samples.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include 50 obese adolescents with Type II Diabetes, 50 obese adolescents without Type II Diabetes, and age, gender, race and pubertal status-matched normal weight controls.
Criteria

Inclusion Criteria:

  1. Obese/Overweight adolescents without T2D who are having their first visit to the Healthy Lifestyle Program at Duke
  2. Obese/Overweight adolescents with T2D followed at Diabetes Clinics at Lenox Baker Children's Hospital
  3. Age, gender, race and pubertal status matched normal weight adolescents presenting for "well child check" at Roxboro Clinics
  4. ≥12 to 18 (inclusive) years of age
  5. Both the subject and one parent/guardian present will need to be able to speak and read English

Exclusion Criteria:

  1. Currently or within the past month taken systemic corticosteroids, antipsychotics, medications for weight loss, topiramate, oral contraceptives or medroxy-progesterone acetate
  2. Children with genetic syndrome causing obesity
  3. Children with decompensated hypothyroidism
  4. Normal weight children with glucosuria as this might indicate undiagnosed diabetes
  5. Children that are pregnant

Information from the National Library of Medicine

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


Contacts
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Contact: Pinar Gumus Balikcioglu, M.D. 9196684002 pinar.gumus@duke.edu
Contact: Denise Simmons, BS 9193237601 denise.f.simmons@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Pinar Gumus Balikcioglu, M.D.    919-668-4002    pinar.gumus@duke.edu   
Sponsors and Collaborators
Duke University
Children's Miracle Network
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Pinar Gumus Balikcioglu, M.D. Pediatric Endocrinology

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02326129     History of Changes
Other Study ID Numbers: Pro00057460
K23DK117067 ( U.S. NIH Grant/Contract )
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases