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

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

Detailed Description
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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

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

Conditions
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Hypothyroidism, Insulin Resistance

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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