This trial is active, not recruiting.

Conditions pregnancy, gestational diabetes mellitus (gdm), type 2 diabetes
Sponsor Qingdao University
Start date August 2013
End date June 2014
Trial size 200 participants
Trial identifier NCT02025673, Betatrophin-Human


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Healthy subjects as control group.
Patients with type 2 diabetes.
Patients with gestational diabetes mellitus.

Primary Outcomes

Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women
time frame: Up to one month

Secondary Outcomes

Correlation of betatrophin concentration with other variables
time frame: Up to one month

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects
Principal investigator Jing Dong, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Qingdao University.