Insulin Resistance in Relation to Hyperthyroidism and Hypothyroidism

May 1, 2024 updated by: Dina Ibrahim Sadek Mohamed, Assiut University
Insulin resistance and its relation to hyperthyrodism and Hypothyroidism

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Thyroid hormones (TH) play an important role in regulating energy balance, metabolism of glucose, and lipids. While TH oppose the action of insulin and stimulate the hepatic gluconeogenesis and glycogenolysis they up-regulate the expression of genes such as glucose transporter type-4 (GLUT--4) and phosphoglycerate kinase, involved in glucose transport and glycolysis, respectively, thus acting synergistically with insulin facilitating glucose disposal and utilization in peripheral tissues.

This indicates a possible interplay between thyroid status and insulin sensitivity. Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. The homeostasis model assessment (HOMA) for IR (HOMA-IR) derives estimates of insulin sensitivity from the mathematical modeling of fasting plasma glucose and insulin concentrations.

Homeostatic model assessment for insulin resistance (HOMA - IR) based on fasting glucose and insulin measurements; derived from the product of the insulin and glucose values divided by a constant, that is, calculated by using the following formula: fasting glucose (mg/dL) X fasting insulin (mU/L) / 405 (for SI units: fasting glucose (mmol/L) X fasting insulin (mU/L) / 22.5) , a value greater than 2 indicates insulin resistance .

In both hyper- as well as hypothyroid groups, there was significant increase in LDL levels. The amount of insulin specifically bound and the number of insulin receptors per cell were inversely correlated with the LDL level. The number of insulin receptors and the amount of insulin bound in the tested subjects with increased LDL were correspondingly low.

Study Type

Observational

Enrollment (Estimated)

100

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Based on determining the main outcome variable, the estimated minimum required sample size is 108cases (36cases in each group ).

The sample size was calculated using G*power software 3.1.9.7., based on the following assumptions:

HbA1C was elevated in 22.3% of hypothyroid group and 21% of hyperthyroid group compared to controls group eleveted only in ( 16.1%) Medium effect size was estimate to be 0.3 Main statistical test is chi_squer test ,goodness of fit Alpha = 0.05, Power = 0.80 Allocation ratio= 1.

Description

Inclusion Criteria:

  • Adult pations above 18 years old

Exclusion Criteria:

  • Any patients with Diabetes mellitus

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
Measure Description
Time Frame
The prevalence of diabetes mellitus among patients with thyroid disorders
Time Frame: baseline
to prove the prevalence of diabetes mellitus is elevated among patients with thyroid disorders
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thyroid and insulin resistance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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