Type2 DiabetesNCT03519529
Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
An observational study of Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Type2 Diabetes
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 20 Apr 2018
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to April 2018 were enrolled in this study.
Who may be able to join
- ● Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.
Who cannot join
- Patients use systemic steroidal anti-inflammatory drugs.
- Patients with an acute infection.
- Patients with acute complication of diabetes.
About this study
Official title: The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D).
Read the detailed description
The investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, HbA1c, SHBG, testosterone, insulin, EPO, C-peptide, glucagon, microalbuminuria, glycemic variation via CGM, carotid plaque, ECG and ultrasonic cardiogram in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to Aprol 2018. The relationship between levels of SHBG, testosterone and glycemic variation/diabetic complications are analysed.
- Conditions
- Type2 Diabetes
- Keywords
- sex hormone-binding globulin
What is being measured
The primary outcome is the main question the study is designed to answer.
sex hormone-binding globulin
the blood sex hormone-binding globulin level of patients
Measured: Day 1
Secondary outcomes (6)
Testosterone
blood testosterone level of patients
Measured: Day 1
EPO
blood erythropoietin level of patients
Measured: Day 1
HbA1c
the glycosylated hemoglobin level of patients
Measured: Day 1
MBG
24h mean blood glucose tested by CGM
Measured: Day 1-4
MAGE
the 24h mean amplitude of glycemic excursion
Measured: Day 1-4
SD
the standard deviation of mean glucose
Measured: Day 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Jan 2015
- Primary completion15 Apr 2018
- Study completion20 Apr 2018
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 Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519529
- Sponsor's protocol ID
- ENDO20180426-01
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding B, Sun R, Zhai XF, Lu TT, Cheng L, Li FF, Hu Y, Ma JH. Association of high circulating testosterone with increased glycaemic variability in type 2 diabetes: A cross-sectional study in China. Diabetes Metab Res Rev. 2019 May;35(4):e3126. doi: 10.1002/dmrr.3126. Epub 2019 Jan 23.
PubMed 30614187
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03519529
- Acronym / sponsor ID
- ENDO20180426-01
- Conditions
- Type2 Diabetes
- Keywords
- sex hormone-binding globulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 9 May 2018 (actual)
- 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.
Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D).
Detailed description
The investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, HbA1c, SHBG, testosterone, insulin, EPO, C-peptide, glucagon, microalbuminuria, glycemic variation via CGM, carotid plaque, ECG and ultrasonic cardiogram in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to Aprol 2018. The relationship between levels of SHBG, testosterone and glycemic variation/diabetic complications are analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to April 2018 were enrolled in this study.
Key inclusion criteria (1 listed)
- ● Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.
Key exclusion criteria (3 listed)
- Patients use systemic steroidal anti-inflammatory drugs.
- Patients with an acute infection.
- Patients with acute complication of diabetes.
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
sex hormone-binding globulin
Time frame: Day 1
the blood sex hormone-binding globulin level of patients
6 secondary outcomes
Testosterone
Time frame: Day 1
EPO
Time frame: Day 1
HbA1c
Time frame: Day 1
MBG
Time frame: Day 1-4
MAGE
Time frame: Day 1-4
SD
Time frame: Day 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 30614187Ding B, Sun R, Zhai XF, Lu TT, Cheng L, Li FF, Hu Y, Ma JH. Association of high circulating testosterone with increased glycaemic variability in type 2 diabetes: A cross-sectional study in China. Diabetes Metab Res Rev. 2019 May;35(4):e3126. doi: 10.1002/dmrr.3126. Epub 2019 Jan 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sex hormone-binding globulin (time frame: Day 1). 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 NCT03519529, 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 11 May 2018.