Clinical trial NCT02025673: Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects
Official title: Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Gestational Diabetes Mellitus (GDM)
Type 2 Diabetes
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 19 healthy pregnant women and 9 pregnant women with gestational diabetes mellitus (GDM) were enrolled in the study. 24 patients with newly diagnosed type 2 diabetes mellitus before treatment, 35 patients with type 2 diabetes mellitus after treatment. Subjects were recruited from patients at the Department of Clinical Endocrinology and Maternity Department, Affiliated Hospital of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women
timeFrame: Up to one month
Secondary outcomes:
measure: Correlation of betatrophin concentration with other variables
timeFrame: Up to one month
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Qingdao University
name: Jing Dong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s00125-013-3071-1.