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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus

NCT00463502

Diabetes Mellitus, Type 2

COMPLETED PHASE4

The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension

NCT01342614

Diabetes Mellitus Essential Hypertension

COMPLETED NA

Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

NCT03183752

Thyroid Nodule Insulin Resistance

COMPLETED NA

Metformin Plus Insulin on Non-obese Autoimmune Diabetes

NCT03513874

Type 1 Diabetes Mellitus Autoimmune Diabetes

UNKNOWN PHASE4

Metformin in Postmenopausal Women With Metabolic Syndrome

NCT01342744

Metabolic Syndrome

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothyroidism Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

metformin ,life style

known to have hypothyroidism with insulin resistance received metformin (1000mg,once daily per oral ) and applied life style modification

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

placebo

known to have hypothyroidism with insulin resistance not received metformin and not applied life style modification

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

life style modification

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 )

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No