Back to resultsEffect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
Primary Purpose
Hypothyroidism, Insulin Resistance
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
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 )
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
metformin ,life style
placebo
Arm Description
known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification
known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification
Outcomes
Primary Outcome Measures
change of waist circumference
change of waist circumference from baseline and at the end of study
Dose of levothyroxine
change of the dose of levothyroxine
change of parameter of metabolic syndrome
change of score of parameter of metabolic syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06096454
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2023 (Anticipated)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
metformin ,life style
Arm Type
Experimental
Arm Description
known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification
Arm Title
placebo
Arm Type
No Intervention
Arm Description
known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
life style modification
Intervention Description
effect of life style modification and metformin on hypothyroidism with insulin resistance
Primary Outcome Measure Information:
Title
change of waist circumference
Description
change of waist circumference from baseline and at the end of study
Time Frame
6 months
Title
Dose of levothyroxine
Description
change of the dose of levothyroxine
Time Frame
6 months
Title
change of parameter of metabolic syndrome
Description
change of score of parameter of metabolic syndrome
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hossam mohamed youssef, MBBCh
Phone
01014647504
Email
dr.hossam.youssef96@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad HM AbdEllah-Alawi, MD
Phone
+201115353591
Email
mhmdifferent@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad HM AbdEllah-Alawi, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23720280
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.
Results Reference
background
PubMed Identifier
18493227
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.
Results Reference
background
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Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance
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