NCT03001336

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
Last Updated

December 23, 2016

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

December 12, 2016

Last Update Submit

December 19, 2016

Conditions

Keywords

ThyroidDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 24h-albuminuria

    Day One

Interventions

This is a cross-sectional study

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusThyroid Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 23, 2016

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

December 23, 2016

Record last verified: 2011-01

Data Sharing

IPD Sharing
Will not share