Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance

October 21, 2023 updated by: Mohammad Hasan AbdEllah, Assiut University
The aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypothyroidism happens when the thyroid does not create and release enough thyroid hormone in the body this make the metabolism slow down .

Thyroid hormones T3 and T4 maintain a fine balance of glucose homeostasis by acting as insulin agonistic and antagonistic. Hypothyroidism can break this equilibrium and alter glucose metabolism, which can lead to insulin resistance.

Insulin resistance is defined clinically as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization in an individual as much as it does in a normal population.

In this work we assess the lifestyle modification (i.e. diet and exercise)and metformin on insulin resistance

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Description

Inclusion Criteria:

  • 1_ above 18 years with insulin resistance criteria according (The American Association of Clinical Endocrinologists (AACE)

    • 1)BMI of 25 kg/m2 or higher
    • 2)Waist circumference of more than 102 cm in men or more than 88 cm in women
    • 3)Triglyceride level of 150 mg/dl . or higher.
    • 4) HDL-C level of less than 40 mg/dl in men or less than 50 mg/dl in women
    • 5)Blood pressure of 130 /85 mmhg or higher
    • 6)Fasting glucose level of 110 ـ126 mg /dl

    • 7)Glucose level of more than 140 mg/dl2 hour after administration of 75 g of glucose

      2_ Patients known to have hypothyroidism and achieving diagnostic criteria of insulin resistance

Exclusion Criteria:

  • Patients don't have other secondary causes of insulin resistance i.e. acromegaly, Cushing syndrome 3- patient have renal or hepatic impairment (contraindication to metformin )

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin ,life style
known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification
Drug: Metformin
effect of life style modification and metformin on hypothyroidism with insulin resistance
Other Names:
  • life style modification
No Intervention: placebo
known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of waist circumference
Time Frame: 6 months
change of waist circumference from baseline and at the end of study
6 months
Dose of levothyroxine
Time Frame: 6 months
change of the dose of levothyroxine
6 months
change of parameter of metabolic syndrome
Time Frame: 6 months
change of score of parameter of metabolic syndrome
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohammad HM AbdEllah-Alawi, MD, 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)

November 20, 2023

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 21, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • life style in hypothyroidism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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