Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
Study Details
Study Description
Brief Summary
The aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: metformin ,life style known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification |
Drug: Metformin
effect of life style modification and metformin on hypothyroidism with insulin resistance
Other Names:
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No Intervention: placebo known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification |
Outcome Measures
Primary Outcome Measures
- change of waist circumference [6 months]
change of waist circumference from baseline and at the end of study
- Dose of levothyroxine [6 months]
change of the dose of levothyroxine
- change of parameter of metabolic syndrome [6 months]
change of score of parameter of metabolic syndrome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
1_ above 18 years with insulin resistance criteria according (The American Association of Clinical Endocrinologists (AACE)
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1)BMI of 25 kg/m2 or higher
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2)Waist circumference of more than 102 cm in men or more than 88 cm in women
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3)Triglyceride level of 150 mg/dl . or higher.
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- HDL-C level of less than 40 mg/dl in men or less than 50 mg/dl in women
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5)Blood pressure of 130 /85 mmhg or higher
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6)Fasting glucose level of 110 ـ126 mg /dl
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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 )
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: Mohammad HM AbdEllah-Alawi, MD, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- life style in hypothyroidism