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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096454
Collaborator
(none)
100
Enrollment
2
Arms
11.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
Anticipated Study Start Date :
Nov 20, 2023
Anticipated Primary Completion Date :
Sep 20, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. change of waist circumference [6 months]

      change of waist circumference from baseline and at the end of study

    2. Dose of levothyroxine [6 months]

      change of the dose of levothyroxine

    3. change of parameter of metabolic syndrome [6 months]

      change of score of parameter of metabolic syndrome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

      1. 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 )

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Mohammad HM AbdEllah-Alawi, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohammad Hasan AbdEllah, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06096454
    Other Study ID Numbers:
    • life style in hypothyroidism
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Insulin Resistance
    Hypothyroidism
    Metformin

    Study Results

    No Results Posted as of Oct 23, 2023