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

NCT ID: NCT02025673

Last Updated: 2014-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Gestational Diabetes Mellitus (GDM) Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Controls

Healthy subjects as control group.

No interventions assigned to this group

Type 2 diabetes

Patients with type 2 diabetes.

No interventions assigned to this group

Gestational diabetes mellitus

Patients with gestational diabetes mellitus.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Jing Dong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Dong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Medical College of Qingdao University

References

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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.

Reference Type RESULT
PMID: 24078058 (View on PubMed)

Other Identifiers

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Betatrophin-Human

Identifier Type: -

Identifier Source: org_study_id

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