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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypothyroidism; Insulin Resistance

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06096454

life style in hypothyroidism

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

metformin ,life style

Experimental group

Description:

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

Treatment:

Drug: Metformin

placebo

No Intervention group

Description:

known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification