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

Phase 4

Not yet recruiting

• Conditions: Hypothyroidism; Insulin Resistance
• Interventions: Drug: Metformin

• Registration Number: NCT06096454
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-29
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Study Start: 2023-11-20
• Primary Completion: 2024-09-20
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin ,life style	Metformin	known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification

Primary Outcome Measures

Name	Time	Method
Dose of levothyroxine	6 months	change of the dose of levothyroxine
change of parameter of metabolic syndrome	6 months	change of score of parameter of metabolic syndrome
change of waist circumference	6 months	change of waist circumference from baseline and at the end of study