HypothyroidismNCT06699069
Effect of Exercise on Irisin Levels of Hypothyroid Rats
A study testing Hypothyroid group and Hypothyroid group received exercise in people with Hypothyroidism, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats. Read more about this study
- Who is it for?
- Ages 6 to 8 weeks, men only
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Hypothyroid group and Hypothyroid group received exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male adult rats weighing approx. 200-250gms
- 6 to 8 week old rats
Who cannot join
- Female rats will be excluded.
- Rats with any obvious pathology
- The rats weighing >200gm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise on Serum Irisin Levels in Hypothyroid Sprague Dawley Rats
The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats.
Read the detailed description
Contracting skeletal muscle acts as an endocrine organ, capable of secreting hormones called myokines, such as interleukin 1, Interleukin 15 and Irisin. Myokines are important for regulation of glucose and lipid metabolism. Among these, irisin, is an exercise induced polypeptide, secreted mainly by skeletal muscles and adipose tissue. Irisin is also secreted in small amounts from cardiac muscle, pancreas and sebaceous glands. It is cleaved and secreted from fibronectin type III domain-containing protein 5 (FNDC5 gene) and is regulated by the peroxisome proliferator-activated receptor-γ co activator 1-α (PGC1-α) .
The most important function of Irisin is thermogenesis, by inducing the browning of white adipose tissue, thereby increasing energy consumption, encouraging weight loss and decreasing dietary insulin resistance. Linking Irisin levels with obesity, its mechanism shows that after exercise there is up regulation of a thermogenin ,an Uncoupling Protein-1 (UCP-1) Thyroid hormone also plays an important role in glucose-lipid metabolism and energy homeostasis. Hypothyroidism, a decrease in thyroid hormone levels, can lead to obesity and metabolic syndrome. It has been found that thyroid hormone is also involved in thermogenesis by inducing browning of white adipose tissue, through thyroid hormone receptors. In hypothyroidism, many metabolic processes in the body are affected such as differentiation in the adipose tissue. Increased thyroid stimulating hormone (TSH) causes adipogenesis by stimulating pre-adipocyte differentiation directly through the receptors in the adipose tissue . Fatty tissue is increased by adipocyte hypertrophy as a consequence of previous adipogenesis, and newly formed adipocyte-8, resulting in clinical obesity.
FNDC5 (Fibronectin type III domain-containing protein 5), which is the precursor of irisin, is a protein that is encoded by the FNDC5 gene, is present in many tissues, including the thyroid tissue and therefore effects thyroid hormone.
Dysregulation of both Thyroid and Irisin hormones result in metabolic syndrome. The metabolic syndrome is a common metabolic disorder that has been linked to the increasing prevalence of obesity. By regulating thyroid hormone levels, irisin has a powerful impact on metabolism and thermogenesis. The association of irisin with the thyroid hormone in hypothyroidism still remains unknown and is controversial, and requires further confirmatory studies on experimental models.
Regular exercise is known to have significant beneficial effects on the metabolic health and this is mediated by skeletal muscle. Contracting skeletal muscle is the source of Irisin. Studies have shown an increase in post exercise Irisin levels
- Conditions
- Hypothyroidism
- Being tested
- Control or Euthyroid group, Hypothyroid group, Hypothyroid group received exercise
- Keywords
- Exercise, Irisin, Hypothyroidism
- Medical subject headings
- Hypothyroidism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control or Euthyroid groupOther
Fed on normal standard diet
Hypothyroid groupOther
Experimental hypothyroidism will be induced by administration of propylthiouracil for three weeks in the form of tablets diluted in water
Hypothyroid group received exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control or Euthyroid) total number of rats=20 | Experimental | Fed on normal standard diet Receives: 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 Receives: 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. Receives: Other: Hypothyroid group received exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Triiodothyronine T3
Estimation of serum free triiodothyronine (FT3) levels (ng/ml) by radioimmunoassay
Measured: 11th week
Serum Thyroxine
Estimation of serum free thyroxin (FT4) levels (μg/dl) by radioimmunoassay
Measured: 11th week
Serum Irisin
Estimation of serum irisin levels (μg/ml) by using enzyme - linked immunosorbent assay (ELISA) using irisin competitive ELISA Kit
Measured: 11th week
Serum Thyroid Stimulating Hormone
By radioimmunoassay
Measured: 11th week
Serum Triglycerides (TG)
By enzymatic method using micro lab analyzer
Measured: 11th week
Serum High Density Lipoproteins (HDL)
Determined by precipitating method using micro lab analyzer
Measured: 11th week
Serum Low Density Lipoproteins (LDL)
LDL= Total cholesterol-HDL-TG/5
Measured: 11th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start20 Feb 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shazia Ali, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699069
- Sponsor's protocol ID
- IRC/20/232 Fatima Iqbal
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30402097Korta 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.
PubMed 31443222Gizaw 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.
PubMed 30151293Uc 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.
PubMed 29777516Maalouf 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.
PubMed 31065382Deshmukh 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.
PubMed 30675157Abdel Moety DA. Evaluation of Serum Irisin and Creatine Kinase Levels in Hypo- and Hyperthyroid Rats. Al-Azhar Med J. 2017;46(1):163-74.
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.
PubMed 26201007Yang 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.
PubMed 30722716Rochlani 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.
PubMed 28639538Teixeira 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.
PubMed 32489580Kurdiova 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.
PubMed 24297848
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Serum Irisin Levels in Hypothyroid Sprague Dawley Rats
- ClinicalTrials.gov ID
- NCT06699069
- Acronym / sponsor ID
- IRC/20/232 Fatima Iqbal
- Conditions
- Hypothyroidism
- Keywords
- Exercise, Irisin, Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats.
Detailed description
Contracting skeletal muscle acts as an endocrine organ, capable of secreting hormones called myokines, such as interleukin 1, Interleukin 15 and Irisin. Myokines are important for regulation of glucose and lipid metabolism. Among these, irisin, is an exercise induced polypeptide, secreted mainly by skeletal muscles and adipose tissue. Irisin is also secreted in small amounts from cardiac muscle, pancreas and sebaceous glands. It is cleaved and secreted from fibronectin type III domain-containing protein 5 (FNDC5 gene) and is regulated by the peroxisome proliferator-activated receptor-γ co activator 1-α (PGC1-α) .
The most important function of Irisin is thermogenesis, by inducing the browning of white adipose tissue, thereby increasing energy consumption, encouraging weight loss and decreasing dietary insulin resistance. Linking Irisin levels with obesity, its mechanism shows that after exercise there is up regulation of a thermogenin ,an Uncoupling Protein-1 (UCP-1) Thyroid hormone also plays an important role in glucose-lipid metabolism and energy homeostasis. Hypothyroidism, a decrease in thyroid hormone levels, can lead to obesity and metabolic syndrome. It has been found that thyroid hormone is also involved in thermogenesis by inducing browning of white adipose tissue, through thyroid hormone receptors. In hypothyroidism, many metabolic processes in the body are affected such as differentiation in the adipose tissue. Increased thyroid stimulating hormone (TSH) causes adipogenesis by stimulating pre-adipocyte differentiation directly through the receptors in the adipose tissue . Fatty tissue is increased by adipocyte hypertrophy as a consequence of previous adipogenesis, and newly formed adipocyte-8, resulting in clinical obesity.
FNDC5 (Fibronectin type III domain-containing protein 5), which is the precursor of irisin, is a protein that is encoded by the FNDC5 gene, is present in many tissues, including the thyroid tissue and therefore effects thyroid hormone.
Dysregulation of both Thyroid and Irisin hormones result in metabolic syndrome. The metabolic syndrome is a common metabolic disorder that has been linked to the increasing prevalence of obesity. By regulating thyroid hormone levels, irisin has a powerful impact on metabolism and thermogenesis. The association of irisin with the thyroid hormone in hypothyroidism still remains unknown and is controversial, and requires further confirmatory studies on experimental models.
Regular exercise is known to have significant beneficial effects on the metabolic health and this is mediated by skeletal muscle. Contracting skeletal muscle is the source of Irisin. Studies have shown an increase in post exercise Irisin levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Control or Euthyroid) total number of rats=20 | Experimental | Other: Control or Euthyroid groupFed on normal standard diet |
| Group II (Hypothyroid) total number of rats=20 | Experimental | Other: Hypothyroid groupExperimental hypothyroidism will be induced by administration of propylthiouracil for three weeks in the form of tablets diluted in water |
| Group III (Hypothyroid received exercise) total number of rats=20 | Experimental | Other: Hypothyroid group received exerciseRats will be subjected to chronic swimming. The swimming protocol will consist of 8 weeks of low-intensity swimming exercise. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male adult rats weighing approx. 200-250gms
- 6 to 8 week old rats
Key exclusion criteria (3 listed)
- Female rats will be excluded.
- Rats with any obvious pathology
- The rats weighing >200gm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control or Euthyroid groupFed on normal standard diet | Other | Group I (Control or Euthyroid) total number of rats=20 |
| Hypothyroid groupExperimental hypothyroidism will be induced by administration of propylthiouracil for three weeks in the form of tablets diluted in water | Other | Group II (Hypothyroid) total number of rats=20 |
| Hypothyroid group received exerciseRats 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 | Other | Group III (Hypothyroid received exercise) total number of rats=20 |
Primary outcome
Serum Triiodothyronine T3
Time frame: 11th week
Estimation of serum free triiodothyronine (FT3) levels (ng/ml) by radioimmunoassay
Serum Thyroxine
Time frame: 11th week
Estimation of serum free thyroxin (FT4) levels (μg/dl) by radioimmunoassay
Serum Irisin
Time frame: 11th week
Estimation of serum irisin levels (μg/ml) by using enzyme - linked immunosorbent assay (ELISA) using irisin competitive ELISA Kit
Serum Thyroid Stimulating Hormone
Time frame: 11th week
By radioimmunoassay
Serum Triglycerides (TG)
Time frame: 11th week
By enzymatic method using micro lab analyzer
Serum High Density Lipoproteins (HDL)
Time frame: 11th week
Determined by precipitating method using micro lab analyzer
Serum Low Density Lipoproteins (LDL)
Time frame: 11th week
LDL= Total cholesterol-HDL-TG/5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 30402097Martinez 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.
- Background: PubMed 31443222Korta 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.
- Background: PubMed 30151293Gizaw 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.
- Background: PubMed 29777516Uc 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.
- Background: PubMed 31065382Maalouf 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.
- Background: PubMed 30675157Deshmukh 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.
- BackgroundAbdel 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: PubMed 26201007Ates 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.
- Background: PubMed 30722716Yang 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.
- Background: PubMed 28639538Rochlani 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.
- Background: PubMed 32489580Teixeira 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.
- Background: PubMed 24297848Kurdiova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shazia Ali, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothyroid group and Hypothyroid group received exercise in people with Hypothyroidism, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Triiodothyronine T3 (time frame: 11th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699069, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.