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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02025673

Enrollment

200

Registered

2014-01-01

Start date

2013-08-31

Completion date

2014-07-31

Last updated

2014-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Correlation of betatrophin concentration with other variables	Up to one month

Outcome results