Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects

• Conditions: Gestational Diabetes Mellitus (GDM); Type 2 Diabetes; Pregnancy

• Registration Number: NCT02025673
• Lead Sponsor: Qingdao University

Brief Summary

Betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation, improves glucose tolerance and regulates lipids metabolism. A recent study showed that circulating concentrations of betatrophin doubled in type 1 diabetes. The objective of this study is to investigate the association of serum betatrophin levels with the progression of diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in gestational diabetes patients and pregnant women.

Detailed Description

200 subjects were recruited in this study and divided into six groups for comparison of the serum betatrophin. 70 healthy subjects and 20 healthy young volunteers were enrolled for investigating the role of betatrophin in energy homeostasis and the circadian rhythm. 50 patients with type 2 diabetes were classified into three groups by the stage of diabetic retinopathy. Rank test was used to analyze the correlation between the progression of diabetic retinopathy and circulating betatrophin. Betatrophin were measured by a commercially available enzyme-linked immunosorbent assay and confirmed via Western Blot.

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-30
• Last Update Submitted: 2013-12-30
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Type 2 diabetes mellitus patients
• Patients with HbA1c >or= 7.0%

Exclusion Criteria

• Participation in other investigational Clinical Trial
• Type 1 diabetes mellitus patients
• Patients with history of severe hepatic dysfunction
• Treatment with antifungal agent especially Miconazole
• Patients with active smoking or history of smoking cessation less than 2 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women	Up to one month

Secondary Outcome Measures

Name	Time	Method
Correlation of betatrophin concentration with other variables	Up to one month