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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096454
• Other study ID #: life style in hypothyroidism
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 20, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: hossam mohamed youssef, MBBCh
• Phone: 01014647504
• Email: dr.hossam.youssef96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 30, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?126 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 )

Related Conditions & MeSH terms

• Hypothyroidism
• Insulin Resistance

Intervention

Drug:
• Metformin
effect of life style modification and metformin on hypothyroidism with insulin resistance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of waist circumference	change of waist circumference from baseline and at the end of study	6 months
Primary	Dose of levothyroxine	change of the dose of levothyroxine	6 months
Primary	change of parameter of metabolic syndrome	change of score of parameter of metabolic syndrome	6 months