Thyroid Function and Diabetes Complications

Diabetes Clinical Trial

Official title:

Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001336
• Other study ID #: DIA-THY-1
• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Complications
• Diabetes Mellitus
• Thyroid Disease
• Thyroid Diseases

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