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Report for Clinical Trial NCT03195400

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pathogenesis of Youth Onset Type 2 Diabetes and Prediabetes

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.

NCT03195400 IGT - Impaired Glucose Tolerance T2D
MeSH:Prediabetic State Glucose Intolerance

4 Interventions

Name: Oral Glucose Tolerance Test

Description: 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.
Type: Diagnostic Test
Group Labels: 2

CC Genotype TT Genotype

Name: Hyperglycemic Clamp

Description: Test of beta-cell function and insulin secretion. Involves increasing and maintaining blood glucose concentration with IV variable infusion of dextrose.
Type: Diagnostic Test
Group Labels: 2

CC Genotype TT Genotype

Name: Isoglycemic Intravenous Glucose Test

Description: Test which exposes pancreas to blood glucose levels matched to the ones obtained at the OGTT.
Type: Diagnostic Test
Group Labels: 2

CC Genotype TT Genotype

Name: Hyperinsulinemic Euglycemic Clamp and 2H20

Description: Test is used to assess insulin effects on hepatic glucose production.
Type: Diagnostic Test
Group Labels: 2

CC Genotype TT Genotype

Primary Outcomes

Description: An oral glucose tolerance test will be performed to assess glucose tolerance status to determine if subjects are pre-IGT or IGT

Measure: Glucose tolerance status

Time: Baseline

Description: DNA screening to measure whether subject is CC or TT genotype

Measure: Genotype

Time: Baseline

Description: AIRmax stimulation test during the hyperglycemic clamp to ascertain the maximal acute insulin response (AIR) to arginine, which is a measure of functional beta cell capacity.

Measure: Beta cell capacity

Time: Baseline

Description: Subjects will undergo the IsoIVGT test with GLP-1 measurements to measure the incretin effect

Measure: Incretin effect

Time: 3weeks to 1 month post Baseline testing

Description: The AIRmax stimulation test during the hyperglycemic clamp will be repeated at 2 years to determine if genotype TCF7L2 contributes to worsening in beta cell function longitudinally

Measure: Beta cell function (longitudinally)

Time: 2 years post Baseline

Description: Measurements from the Hyperinsulinemic Euglycemic Clamp/ 2H20 Study will be used to assess insulin effects on hepatic glucose production and glycerol kinetics isotopes and the deuterium enrichment at carbons 2 and 5 (C2 and C5) of plasma glucose providing information on glucose fluxes

Measure: Hepatic glucose fluxes

Time: 2 months post baseline testing
Time Perspective: Prospective

Cohort

There is one SNP

SNPs

1 rs7903146

To delineate the effects of TCF7L2 rs7903146 on functional Beta-Cell Capacity in obese adolescents with Impaired Glucose Tolerance (IGT) and pre-IGT.

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.


HPO Nodes