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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001336
Other study ID # DIA-THY-1
Secondary ID
Status Completed
Phase N/A
First received December 12, 2016
Last updated December 19, 2016
Start date December 2010
Est. completion date May 2013

Study information

Verified date January 2011
Source Nanjing First Hospital, Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Jiangsu Province Health Department
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date May 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

1. Patients are = 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999.

2. Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).

Exclusion Criteria:

1. Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer.

2. Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives.

3. Patients are pregnant or lactating women.

4. Patients with acute intercurrent illness of diabetes.

5. Patients with an acute infection.

6. Patients with a history of drug abuse alcohol dependence in the past 5 years.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Intervention

Other:
no intervention
This is a cross-sectional study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.) Day One No
Secondary 24h-albuminuria Day One No
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