DiabetesNCT03001336
Thyroid Function and Diabetes Complications
An observational study of Diabetes and Thyroid Disease, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes, Thyroid Disease
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to May 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012 were enrolled in this study.
Who may be able to join
- Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999.
- Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).
Who cannot join
- Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer.
- Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives.
- Patients are pregnant or lactating women.
- Patients with acute intercurrent illness of diabetes.
- Patients with an acute infection.
- Patients with a history of drug abuse alcohol dependence in the past 5 years.
About this study
Official title: Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China
The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM).
Read the detailed description
Aims: We investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).
Subjects: Elderly inhospital patients with T2DM who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.
Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted.
The relationships levels of thyroid function and diabetic complications are analysed.
- Conditions
- Diabetes, Thyroid Disease
- Being tested
- no intervention
- Keywords
- Thyroid, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is a cross-sectional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.)
Measured: Day One
Secondary outcomes (1)
24h-albuminuria
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001336
- Sponsor's protocol ID
- DIA-THY-1
- Status last verified
- Jan 2011
- First submitted
- 12 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China
- ClinicalTrials.gov ID
- NCT03001336
- Acronym / sponsor ID
- DIA-THY-1
- Conditions
- Diabetes, Thyroid Disease
- Keywords
- Thyroid, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Dec 2016 (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.
The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM).
Detailed description
Aims: We investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).
Subjects: Elderly inhospital patients with T2DM who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.
Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted.
The relationships levels of thyroid function and diabetic complications are analysed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012 were enrolled in this study.
Key inclusion criteria (2 listed)
- Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999.
- Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).
Key exclusion criteria (6 listed)
- Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer.
- Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives.
- Patients are pregnant or lactating women.
- Patients with acute intercurrent illness of diabetes.
- Patients with an acute infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is a cross-sectional study | Other | – |
Primary outcome
Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.)
Time frame: Day One
1 secondary outcome
24h-albuminuria
Time frame: Day One
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 23 Dec 2016.
- Individual participant dataSharing planned: No
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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 Diabetes and Thyroid Disease, 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 2 inclusion and 6 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 23 Dec 2016. 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?
Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.) (time frame: Day One). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2016.