NCT06699069

Brief Summary

The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

February 2, 2021

Last Update Submit

November 19, 2024

Conditions

Keywords

ExerciseIrisinHypothyroidism

Outcome Measures

Primary Outcomes (7)

  • Serum Triiodothyronine T3

    Estimation of serum free triiodothyronine (FT3) levels (ng/ml) by radioimmunoassay

    11th week

  • Serum Thyroxine

    Estimation of serum free thyroxin (FT4) levels (μg/dl) by radioimmunoassay

    11th week

  • Serum Irisin

    Estimation of serum irisin levels (μg/ml) by using enzyme - linked immunosorbent assay (ELISA) using irisin competitive ELISA Kit

    11th week

  • Serum Thyroid Stimulating Hormone

    By radioimmunoassay

    11th week

  • Serum Triglycerides (TG)

    By enzymatic method using micro lab analyzer

    11th week

  • Serum High Density Lipoproteins (HDL)

    Determined by precipitating method using micro lab analyzer

    11th week

  • Serum Low Density Lipoproteins (LDL)

    LDL= Total cholesterol-HDL-TG/5

    11th week

Study Arms (3)

Group I (Control or Euthyroid) total number of rats=20

EXPERIMENTAL

Fed on normal standard diet

Other: Control or Euthyroid group

Group II (Hypothyroid) total number of rats=20

EXPERIMENTAL

Experimental hypothyroidism will be induced by administration of propylthiouracil for three weeks in the form of tablets diluted in water

Other: Hypothyroid group

Group III (Hypothyroid received exercise) total number of rats=20

EXPERIMENTAL

Rats will be subjected to chronic swimming. The swimming protocol will consist of 8 weeks of low-intensity swimming exercise.

Other: Hypothyroid group received exercise

Interventions

Fed on normal standard diet

Group I (Control or Euthyroid) total number of rats=20

Experimental hypothyroidism will be induced by administration of propylthiouracil for three weeks in the form of tablets diluted in water

Group II (Hypothyroid) total number of rats=20

Rats will be subjected to chronic swimming. The swimming protocol will consist of 8 weeks of low-intensity swimming exercise. The exercise groups will be adapted to a round water tank (70 cm × 70 cm) containing water at 28 ± 2°C for 3 days (10-45 min/day). The rats will then begin swimming, 45 min/day for the first two weeks at 10am and 60 min/day for the last six weeks at 10am

Group III (Hypothyroid received exercise) total number of rats=20

Eligibility Criteria

Age6 Weeks - 8 Weeks
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale Sprague Dawley Rats
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male adult rats weighing approx. 200-250gms
  • to 8 week old rats

You may not qualify if:

  • Female rats will be excluded.
  • Rats with any obvious pathology
  • The rats weighing \>200gm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Health

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (12)

  • Martinez Munoz IY, Camarillo Romero EDS, Garduno Garcia JJ. Irisin a Novel Metabolic Biomarker: Present Knowledge and Future Directions. Int J Endocrinol. 2018 Oct 9;2018:7816806. doi: 10.1155/2018/7816806. eCollection 2018.

    PMID: 30402097BACKGROUND
  • Korta P, Pochec E, Mazur-Bialy A. Irisin as a Multifunctional Protein: Implications for Health and Certain Diseases. Medicina (Kaunas). 2019 Aug 15;55(8):485. doi: 10.3390/medicina55080485.

    PMID: 31443222BACKGROUND
  • Gizaw M, Anandakumar P, Debela T. A Review on the Role of Irisin in Insulin Resistance and Type 2 Diabetes Mellitus. J Pharmacopuncture. 2017 Dec;20(4):235-242. doi: 10.3831/KPI.2017.20.029. Epub 2017 Oct 10.

    PMID: 30151293BACKGROUND
  • Uc ZA, Gorar S, Mizrak S, Gullu S. Irisin levels increase after treatment in patients with newly diagnosed Hashimoto thyroiditis. J Endocrinol Invest. 2019 Feb;42(2):175-181. doi: 10.1007/s40618-018-0899-8. Epub 2018 May 18.

    PMID: 29777516BACKGROUND
  • Maalouf GE, El Khoury D. Exercise-Induced Irisin, the Fat Browning Myokine, as a Potential Anticancer Agent. J Obes. 2019 Apr 1;2019:6561726. doi: 10.1155/2019/6561726. eCollection 2019.

    PMID: 31065382BACKGROUND
  • Deshmukh V, Farishta F, Bhole M. Thyroid Dysfunction in Patients with Metabolic Syndrome: A Cross-Sectional, Epidemiological, Pan-India Study. Int J Endocrinol. 2018 Dec 25;2018:2930251. doi: 10.1155/2018/2930251. eCollection 2018.

    PMID: 30675157BACKGROUND
  • Abdel Moety DA. Evaluation of Serum Irisin and Creatine Kinase Levels in Hypo- and Hyperthyroid Rats. Al-Azhar Med J. 2017;46(1):163-74.

    BACKGROUND
  • Ates I, Altay M, Topcuoglu C, Yilmaz FM. Circulating levels of irisin is elevated in hypothyroidism, a case-control study. Arch Endocrinol Metab. 2016 Apr;60(2):95-100. doi: 10.1590/2359-3997000000077. Epub 2015 Jul 21.

    PMID: 26201007BACKGROUND
  • Yang N, Zhang H, Gao X, Miao L, Yao Z, Xu Y, Wang G. Role of irisin in Chinese patients with hypothyroidism: an interventional study. J Int Med Res. 2019 Apr;47(4):1592-1601. doi: 10.1177/0300060518824445. Epub 2019 Feb 6.

    PMID: 30722716BACKGROUND
  • Rochlani Y, Pothineni NV, Kovelamudi S, Mehta JL. Metabolic syndrome: pathophysiology, management, and modulation by natural compounds. Ther Adv Cardiovasc Dis. 2017 Aug;11(8):215-225. doi: 10.1177/1753944717711379. Epub 2017 Jun 22.

    PMID: 28639538BACKGROUND
  • Teixeira PFDS, Dos Santos PB, Pazos-Moura CC. The role of thyroid hormone in metabolism and metabolic syndrome. Ther Adv Endocrinol Metab. 2020 May 13;11:2042018820917869. doi: 10.1177/2042018820917869. eCollection 2020.

    PMID: 32489580BACKGROUND
  • Kurdiova T, Balaz M, Vician M, Maderova D, Vlcek M, Valkovic L, Srbecky M, Imrich R, Kyselovicova O, Belan V, Jelok I, Wolfrum C, Klimes I, Krssak M, Zemkova E, Gasperikova D, Ukropec J, Ukropcova B. Effects of obesity, diabetes and exercise on Fndc5 gene expression and irisin release in human skeletal muscle and adipose tissue: in vivo and in vitro studies. J Physiol. 2014 Mar 1;592(5):1091-107. doi: 10.1113/jphysiol.2013.264655. Epub 2013 Dec 2.

    PMID: 24297848BACKGROUND

MeSH Terms

Conditions

HypothyroidismMotor Activity

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Shazia Ali, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

November 21, 2024

Study Start

February 20, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations