Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

• Registration Number: NCT01055093
• Lead Sponsor: German Diabetes Center

Brief Summary

The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.

Detailed Description

In detail, the following questions will be answered:

1. Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis?

2. Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)?

3. Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08
• Primary Completion: 2025-09
• Study Completion: 2035-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Clinical diagnosis of diabetes mellitus according to ADA criteria
• Age 18-69
• Diabetes duration since diagnosis < 12 months
• Control cohort: proven normal glucose tolerance according to ADA criteria

Exclusion Criteria

• Diabetes mellitus category 3 B-H (ADA criteria)
• Pregnancy
• Severe renal, liver or heart disease
• malignant cancer
• severe psychiatric illness or addiction
• participation in an intervention trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of insulin sensitivity (M-Value)	2 and 5 years	measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary Outcome Measures

Name	Time	Method
Incidence of any diabetic complication	2-10 years	The prevalence of diabetic complications
Change of insulin secretion	2 and 5 years	measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

Trial Locations

Locations (1)

German Diabetes Center; 🇩🇪 Düsseldorf, North-Rhine Westphalia, Germany