Clinical trial NCT06096454: Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
Official title: Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hypothyroidism
Insulin Resistance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 )

Primary outcomes:
measure: change of waist circumference
timeFrame: 6 months
measure: Dose of levothyroxine
timeFrame: 6 months
measure: change of parameter of metabolic syndrome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammad HM AbdEllah-Alawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts CK, Hevener AL, Barnard RJ. Metabolic syndrome and insulin resistance: underlying causes and modification by exercise training. Compr Physiol. 2013 Jan;3(1):1-58. doi: 10.1002/cphy.c110062.
citation: Crandall JP, Knowler WC, Kahn SE, Marrero D, Florez JC, Bray GA, Haffner SM, Hoskin M, Nathan DM; Diabetes Prevention Program Research Group. The prevention of type 2 diabetes. Nat Clin Pract Endocrinol Metab. 2008 Jul;4(7):382-93. doi: 10.1038/ncpendmet0843. Epub 2008 May 20.