NCT03195400

Pathogenesis of Youth Onset Type 2 Diabetes and Prediabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Type 2 Diabetes (T2D) in obese youth is often preceded by a prediabetic state called: Impaired Glucose Tolerance (IGT), which is associated with a pre-existing defect in insulin secretion. This study intends to determine if genetic factors are associated with defects in insulin secretion, the incretin system and hepatic insulin resistance in obese adolescents. The long-term goal of this study is to generate information on both the genetics as well as the pathophysiology of Type 2 Diabetes in Youth, which ultimately might guide the investigators towards better preventive and treatment avenues.

Detailed description

The Specific Aims of this study are: Aim 1a. To delineate the effects of TCF7L2 rs7903146 on functional Beta-Cell Capacity in obese adolescents with Impaired Glucose Tolerance (IGT) and pre-IGT. Aim 1b. To determine if the risk genotype in TCF7L2 is associated with worsening in beta cell function longitudinally, thereby affecting changes in glucose tolerance. Aim 2. To examine the functional effect of the rs7903146 variant in the TCF7L2 gene on a) incretin effect in obese adolescents with IGT and pre-IGT. Aim 3. To determine the functional effects of TCF7L2 rs7903146 SNP on hepatic glucose fluxes in obese adolescents with IGT and pre-IGT.

Conditions

• IGT - Impaired Glucose Tolerance
• T2D

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral Glucose Tolerance Test	The oral glucose tolerance test (OGTT) measures the body's ability to use a type of sugar, called glucose, that is the body's main source of energy. An OGTT can be used to diagnose prediabetes and diabetes.
DIAGNOSTIC_TEST	Hyperglycemic Clamp	Test of beta-cell function and insulin secretion. Involves increasing and maintaining blood glucose concentration with IV variable infusion of dextrose.
DIAGNOSTIC_TEST	Isoglycemic Intravenous Glucose Test	Test which exposes pancreas to blood glucose levels matched to the ones obtained at the OGTT.
DIAGNOSTIC_TEST	Hyperinsulinemic Euglycemic Clamp and 2H20	Test is used to assess insulin effects on hepatic glucose production.

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-08-31
• Completion: 2022-08-12
• First posted: 2017-06-22
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States