NCT06096454

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

September 29, 2023

Last Update Submit

October 21, 2023

Conditions

HypothyroidismInsulin Resistance

Outcome Measures

Primary Outcomes (3)

  • change of waist circumference

    change of waist circumference from baseline and at the end of study

    6 months

  • Dose of levothyroxine

    change of the dose of levothyroxine

    6 months

  • change of parameter of metabolic syndrome

    change of score of parameter of metabolic syndrome

    6 months

Study Arms (2)

metformin ,life style

EXPERIMENTAL

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

Drug: Metformin

placebo

NO INTERVENTION

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

Interventions

MetforminDRUG

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

Also known as: life style modification
metformin ,life style

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \_ above 18 years with insulin resistance criteria according (The American Association of Clinical Endocrinologists (AACE)
  • )BMI of 25 kg/m2 or higher
  • )Waist circumference of more than 102 cm in men or more than 88 cm in women
  • )Triglyceride level of 150 mg/dl . or higher.
  • \) HDL-C level of less than 40 mg/dl in men or less than 50 mg/dl in women
  • )Blood pressure of 130 /85 mmhg or higher
  • )Fasting glucose level of 110 ـ126 mg /dl
  • )Glucose level of more than 140 mg/dl2 hour after administration of 75 g of glucose
  • \_ Patients known to have hypothyroidism and achieving diagnostic criteria of insulin resistance

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23720280BACKGROUND

  • 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.

    PMID: 18493227BACKGROUND

MeSH Terms

Conditions

HypothyroidismInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mohammad HM AbdEllah-Alawi, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hossam mohamed youssef, MBBCh

CONTACT

01014647504dr.hossam.youssef96@gmail.com

Mohammad HM AbdEllah-Alawi, MD

CONTACT

+201115353591mhmdifferent@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 23, 2023

Study Start

November 20, 2023

Primary Completion

September 20, 2024

Study Completion

October 30, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share