Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT04662866
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Glucose Metabolism in South Asian Women With IGT or IFG. DIAbetes in South Asians - DIASA 3: A 12-week Intervention Trial With Oral Antidiabetic Medication to Improve Hepatic and Whole Body Insulin Sensitivity
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIASA3
Brief Summary:
This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, double-blind, randomized controlled intervention trial, the following drugs will be tested head-to-head: Metformin, Pioglitazone, Empagliflozin and Linagliptin. Additional, exploratory outcomes include whole body insulin sensitivity, insulin secretion and other markers of glucose and lipid metabolism, measured by the euglycemic clamp with stable isotope tracer dilution, indirect calorimetry and CT-measurements of abdominal adipose tissue compartment volumes and hepatic and pancreatic volume and attenuation.
The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity.
The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity.
Detailed Description:
Background: South Asians (SA) have a high prevalence of type 2 diabetes (T2D). SA i Norway develop T2D approximately 10 years earlier than Nordic subjects (NO).T2D in SA is often poorly regulated with increased risk of complications.
Research hypothesis: South Asian subjects with Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) have a high degree of hepatic insulin resistance. Treatment with certain oral antidiabetic drugs will improve hepatic insulin sensitivity more than others.
Primary objective: To assess which of four oral antidiabetic medications is most effective in improving hepatic insulin sensitivity in women of South Asian origin with IFG/IGT.
Study design: Single-center, randomized, double-blind intervention trial with 4 parallel treatment arms: 1) Metformin 2) Pioglitazone 3) Empagliflozin 4) Linagliptin.
Endogenous glucose production (EGP) and hepatic and whole body insulin sensitivity will be assessed by a 2-step euglycemic, hyperinsulinemic clamp with deuterated glucose tracer. In addition, glucose and lipid metabolism will be assessed by indirect calorimetry (IC), insulin secretion by an oral glucose tolerance test (OGTT), and fatty infiltration in liver by computer tomography (CT).
Recruitment: From South Asian women with IFG/IGT who participated in DIASA 1.
Duration of study: 14 weeks, with a total of four study visits, every 4 weeks, plus two CT scans, at baseline and 12 weeks, and one end of study follow-up telephone visit at 14 weeks. The project is expected to last a maximum of 3 years.
Study population: Women ≥ 18 years of age of South Asian ethnicity with IGT/IFG.
Criteria for evaluation: Efficacy outcome will include evaluation of change in EGP from baseline to 12 weeks. Laboratory parameters of glucose and lipid metabolism. Questionnaires with physical activity and food frequency. Safety and tolerability will be assessed by clinical adverse events and laboratory measurements from randomization to 14 weeks.
Primary outcome: Difference between treatment arms in change in EGP from baseline to 12 weeks.
Explorative outcomes: Difference between treatment arms in change from randomisation to 12 weeks in:
* whole body insulin sensitivity
* HbA1c
* glucose and lipid metabolism measured by IC
* fatty infiltration in liver and visceral adipose tissue.
Statistical Methods: One-way ANOVA, Multiple regression analyses, Paired samples t-tests, longitudinal analyses.
Research hypothesis: South Asian subjects with Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) have a high degree of hepatic insulin resistance. Treatment with certain oral antidiabetic drugs will improve hepatic insulin sensitivity more than others.
Primary objective: To assess which of four oral antidiabetic medications is most effective in improving hepatic insulin sensitivity in women of South Asian origin with IFG/IGT.
Study design: Single-center, randomized, double-blind intervention trial with 4 parallel treatment arms: 1) Metformin 2) Pioglitazone 3) Empagliflozin 4) Linagliptin.
Endogenous glucose production (EGP) and hepatic and whole body insulin sensitivity will be assessed by a 2-step euglycemic, hyperinsulinemic clamp with deuterated glucose tracer. In addition, glucose and lipid metabolism will be assessed by indirect calorimetry (IC), insulin secretion by an oral glucose tolerance test (OGTT), and fatty infiltration in liver by computer tomography (CT).
Recruitment: From South Asian women with IFG/IGT who participated in DIASA 1.
Duration of study: 14 weeks, with a total of four study visits, every 4 weeks, plus two CT scans, at baseline and 12 weeks, and one end of study follow-up telephone visit at 14 weeks. The project is expected to last a maximum of 3 years.
Study population: Women ≥ 18 years of age of South Asian ethnicity with IGT/IFG.
Criteria for evaluation: Efficacy outcome will include evaluation of change in EGP from baseline to 12 weeks. Laboratory parameters of glucose and lipid metabolism. Questionnaires with physical activity and food frequency. Safety and tolerability will be assessed by clinical adverse events and laboratory measurements from randomization to 14 weeks.
Primary outcome: Difference between treatment arms in change in EGP from baseline to 12 weeks.
Explorative outcomes: Difference between treatment arms in change from randomisation to 12 weeks in:
* whole body insulin sensitivity
* HbA1c
* glucose and lipid metabolism measured by IC
* fatty infiltration in liver and visceral adipose tissue.
Statistical Methods: One-way ANOVA, Multiple regression analyses, Paired samples t-tests, longitudinal analyses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: