PregnancyNCT02025673
Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects
An observational study of Pregnancy and Gestational Diabetes Mellitus (GDM), run by Qingdao University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus (GDM), Type 2 Diabetes
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Type 2 diabetes mellitus patients
- Patients with HbA1c >or= 7.0%
Who cannot join
- 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
About this study
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.
Read the 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.
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy subjects as control group. | |
| Type 2 diabetes | Patients with type 2 diabetes. | |
| Gestational diabetes mellitus | Patients with gestational diabetes mellitus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women
Measured: Up to one month
Secondary outcomes (1)
Correlation of betatrophin concentration with other variables
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Dong, Qingdao University
- Investigators
- Jing Dong, Ph.D, Principal investigator, Medical College of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025673
- Sponsor's protocol ID
- Betatrophin-Human
- Status last verified
- Dec 2013
- First submitted
- 24 Dec 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24078058
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02025673
- Acronym / sponsor ID
- Betatrophin-Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Healthy subjects as control group. |
| Type 2 diabetes | – | –Patients with type 2 diabetes. |
| Gestational diabetes mellitus | – | –Patients with gestational diabetes mellitus. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus patients
- Patients with HbA1c >or= 7.0%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women
Time frame: Up to one month
1 secondary outcome
Correlation of betatrophin concentration with other variables
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
- Results publication: PubMed 24078058Espes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Dong, Ph.D principal investigator
Medical College of Qingdao University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Gestational Diabetes Mellitus (GDM), run by Qingdao University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of betatrophin in type 2 diabetes patients, gestational diabetes patients and pregnant women (time frame: Up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02025673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2014.