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

December 30, 2013 updated by: Jing Dong, Qingdao University
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 2 diabetes
Patients with type 2 diabetes.
Healthy Controls
Healthy subjects as control group.
Gestational diabetes mellitus
Patients with gestational diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of betatrophin concentration with other variables
Time Frame: Up to one month
Up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao University

Investigators

  • Principal Investigator: Jing Dong, Ph.D, Medical College of Qingdao University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

December 24, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Betatrophin-Human

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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