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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06096454
Enrollment
100
Registered
2023-10-23
Start date
2023-11-20
Completion date
2024-10-30
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism, Insulin Resistance

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

Interventions

DRUGMetformin

effect of life style modification and metformin on hypothyroidism with insulin resistance

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 )

Design outcomes

Primary

MeasureTime frameDescription
change of waist circumference6 monthschange of waist circumference from baseline and at the end of study
Dose of levothyroxine6 monthschange of the dose of levothyroxine
change of parameter of metabolic syndrome6 monthschange of score of parameter of metabolic syndrome

Contacts

Primary Contacthossam mohamed youssef, MBBCh
dr.hossam.youssef96@gmail.com01014647504
Backup ContactMohammad HM AbdEllah-Alawi, MD
mhmdifferent@aun.edu.eg+201115353591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026