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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02025673
• Other study ID #: Betatrophin-Human
• Status: Active, not recruiting
• Phase: N/A
• First received: December 24, 2013
• Last updated: December 30, 2013
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2013
• Source: Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus (GDM)
• Pregnancy
• Type 2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

References & Publications (1)

Espes D, Lau J, Carlsson PO. Increased circulating levels of betatrophin in individuals with long-standing type 1 diabetes. Diabetologia. 2014 Jan;57(1):50-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women		Up to one month	No
Secondary	Correlation of betatrophin concentration with other variables		Up to one month	No