NCT06399796

Brief Summary

Insulin resistance and its relation to hyperthyrodism and Hypothyroidism

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 all trials

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

May 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 1, 2024

Last Update Submit

May 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The prevalence of diabetes mellitus among patients with thyroid disorders

    to prove the prevalence of diabetes mellitus is elevated among patients with thyroid disorders

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Based on determining the main outcome variable, the estimated minimum required sample size is 108cases (36cases in each group ). The sample size was calculated using G\*power software 3.1.9.7., based on the following assumptions: HbA1C was elevated in 22.3% of hypothyroid group and 21% of hyperthyroid group compared to controls group eleveted only in ( 16.1%) Medium effect size was estimate to be 0.3 Main statistical test is chi\_squer test ,goodness of fit Alpha = 0.05, Power = 0.80 Allocation ratio= 1.

You may qualify if:

  • Adult pations above 18 years old

You may not qualify if:

  • Any patients with Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Chubb SA, Davis WA, Davis TM. Interactions among thyroid function, insulin sensitivity, and serum lipid concentrations: the Fremantle diabetes study. J Clin Endocrinol Metab. 2005 Sep;90(9):5317-20. doi: 10.1210/jc.2005-0298. Epub 2005 Jun 28.

    PMID: 15985488BACKGROUND
  • Raboudi N, Arem R, Jones RH, Chap Z, Pena J, Chou J, Field JB. Fasting and postabsorptive hepatic glucose and insulin metabolism in hyperthyroidism. Am J Physiol. 1989 Jan;256(1 Pt 1):E159-66. doi: 10.1152/ajpendo.1989.256.1.E159.

    PMID: 2643338BACKGROUND
  • Clement K, Viguerie N, Diehn M, Alizadeh A, Barbe P, Thalamas C, Storey JD, Brown PO, Barsh GS, Langin D. In vivo regulation of human skeletal muscle gene expression by thyroid hormone. Genome Res. 2002 Feb;12(2):281-91. doi: 10.1101/gr.207702.

    PMID: 11827947BACKGROUND
  • Singh BM, Goswami B, Mallika V. Association between insulin resistance and hypothyroidism in females attending a tertiary care hospital. Indian J Clin Biochem. 2010 Apr;25(2):141-5. doi: 10.1007/s12291-010-0026-x. Epub 2010 May 27.

    PMID: 23105900BACKGROUND
  • Mari A, Ahren B, Pacini G. Assessment of insulin secretion in relation to insulin resistance. Curr Opin Clin Nutr Metab Care. 2005 Sep;8(5):529-33. doi: 10.1097/01.mco.0000171130.23441.59.

    PMID: 16079624BACKGROUND
  • Sanghvi A, Virji MA, Warty V, Dimasi MJ. Differential suppression of lymphocyte cholesterol synthesis by low density lipoprotein and erythrocyte insulin receptors in normolipidemic subjects. Atherosclerosis. 1983 Dec;49(3):307-18. doi: 10.1016/0021-9150(83)90141-7.

    PMID: 6362680BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 6, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

May 6, 2024

Record last verified: 2024-05