Thyroid Function and Diabetes Complications

December 19, 2016 updated by: Nanjing First Hospital, Nanjing Medical University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day One

Secondary Outcome Measures

Outcome Measure
Time Frame
24h-albuminuria
Time Frame: Day One
Day One

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA-THY-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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