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OpenTrials
Completed

NCT Number: NCT01154244

Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

The purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Bucheon-si, South Korea

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About this study

Primary Objective:To investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in Korea Secondary Objectives:To investigate proportion of patients with severe insulin deficiency at diagnosis,To investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,To investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed, drug naïve type 2 DM patients who gave informed consent, Diagnosis of type 2 DM will be made according to ADA guideline 2009 Exclusion Criteria:Patients age under 18 years

Treatment and study plan

HOMA-IR

Other

Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile

Primary outcomes

  1. insulin resistance assessed using HOMA-IR

    Time frame: within 3months after DM diagnosis

Secondary outcomes

  1. proportion of patients with severe insulin deficiency assessed using C-peptide

    Time frame: within 3months after DM diagnosis

  2. proportion of metabolic syndrome in patients

    Time frame: within 3months after DM diagnosis

  3. proportion of obesity in patients

    Time frame: within 3months after DM diagnosis

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Acronym: SURPRISE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2010
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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