NCT00962221

Brief Summary

Overt hypothyroidism is associated with increased risk for cardiovascular disease (CVD) as indicated by hypertension, hypercholesterolemia, and increased low-density lipoprotein cholesterol (LDL-C) levels. Mild hypothyroidism, also called subclinical hypothyroidism \[SH\] is highly prevalent in elderly subjects, especially in women older than 50 years of age. Whether SH is related as a risk for premature CVD is controversial. It was shown that SH is associated with elevated lipids levels, particularly LDL-cholesterol. However recent evidence suggests that the 'quality' rather than only the 'quantity' of LDL-cholesterol exerts a direct influence on the cardiovascular risk. LDL-cholesterol comprises multiple distinct subclasses that differ in their atherogenic potential. Thus, the proposed study protocol is intended to evaluate the different LDL lipoproteins subclasses in patients with subclinical hypothyroidism.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

August 18, 2009

Last Update Submit

September 7, 2016

Conditions

Subclinical Hypothyroidism

Keywords

LDL lipoprotein subclasses in subclinical hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Evaluation of atherogenic lipoproteins

    enrollment

Study Arms (1)

subclinical hypothyroidism

Patients with subclinical hypothyroidism

Procedure: laboratory analysis

Interventions

laboratory analysisPROCEDURE

laboratory analysis

subclinical hypothyroidism

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients followed at the Endocrine Institute, Haemek Medical Center, Afula, Israel

You may qualify if:

  • Subjects with subclinical hypothyroidism

You may not qualify if:

  • Patients taking L-thyroxin therapy
  • Patients with known cardiovascular, cerebral or peripheral atherosclerotic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Institute, Haemek Medical Center

Afula, 18101, Israel

Location

Study Officials

  • Rafael Luboshitzky, MD

    Endocrine Institute, Haemek Medical Center, Afula, Israel

    STUDY DIRECTOR

  • Manfredi Rizzo, MD

    University of Palermo

    STUDY CHAIR

  • Giatgen Spinas, MD

    University of Zurich

    STUDY CHAIR

  • Kaspar Berneis, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

IL(1)