Novel Biomarker for Development of T2D

NCT02326129 | Completed

• 2 other identifiers: Pro00057460K23DK117067
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Type II

Outcome Measures

Primary Outcomes (3)

• Relationship between 11β-HSD1 and 5α-reductase activity, and measures of insulin resistance

  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

  One year

• Gender and pubertal status

  Investigate the role of gender and pubertal status on 11β-HSD1 and 5α-reductase activity

  One year

• Compare 11β-HSD1 activity and 5α-reductase activity among obese adolescents with T2D, obese adolescents without T2D and normal weight controls

  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.

  One year

Secondary Outcomes (4)

• Relationship between 11β-HSD1 and 5α-reductase activity, and key metabolic signatures associated with insulin resistance

  One year

• Urine metabolic signatures associated with insulin resistance and type 2 diabetes

  One year

• Spot urine for metabolic profiling

  One year

• Metabolic signatures correlate with parameters of glucose tolerance

  One year

Study Arms (3)

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

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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 for urine study and 32 young adults 18-21 years of age obese adolescents without T2D and age, gender, race and pubertal status matched normal weight controls for OGTT sub-study.

You may qualify if:

• Obese/Overweight adolescents/young adults without T2D who are having their first visit to the Healthy Lifestyle Program at Duke or Obese/Overweight adolescents/young adults without T2D recruited from the community at PBRC
• Obese/Overweight adolescents/young adults with prediabetes (HbA1c between 5.7-6.4%) and T2D (HbA1c≥6.5%)followed at Diabetes Clinics or recruited from the community at PBRC
• Age, gender, race and pubertal status matched normal weight adolescents presenting for "well child check" at Roxboro Clinics
• ≥12 to 21 (inclusive) years of age for urine studies
• years of age obese adolescents/young adults without T2D and age, gender, race and pubertal status matched normal weight controls for OGTT sub-study
• Both the subject and one parent/guardian present will need to be able to speak and read English

You may not qualify if:

• Currently or within the past month taken systemic or inhaled corticosteroids, antipsychotics, medications for weight loss, topiramate, acute use of contraceptives (less than 3 months) or medroxy-progesterone acetate, medications to treat ADHD
• Children with any genetic syndrome
• Children with decompensated hypothyroidism (treated with levothyroxine and a TSH \>10 µIU/mL )
• Normal weight children (BMI percentile 5%-\<85%) with glucosuria, as defined by a positive urine glucose dip stick test
• Children and young adults who self report that they are pregnant (pregnancy is excluded in both the main and sub-study)
• Proteinuria, as defined by protein level equal to or above 300 mg/dl (+++) on a urine dip stick test.

Sponsors & Collaborators

• Duke University: lead
• Children's Miracle Network: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Pennington Biomedical Research center

Baton Rouge, Louisiana, 70803, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

24 hour urine samples.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pinar Gumus Balikcioglu, M.D.

  Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: February 1, 2015
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (3)