HyperthyroidismNCT02812888
Serum Betatrophin Levels and Its Influencing Factors in Patients With Hyperthyroidism
An observational study of Hyperthyroidism, run by Hu Hao at 1 site in China.
Trial summary
Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts on various levels of these components. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- thionamide treatment for 3 months
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jun 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with hyperthyroidism would be recruited from the Department of Endocrinology, the First People's Hospital of Xuzhou, from May, 2016, to May, 2017. During the same period, the healthy controls would be selected.
Who may be able to join
- Clinical diagnosis of hyperthyroidism
- Must be drug-naive before recruitment
Who cannot join
- diabetes
- hypertension
- cancer
- pregnancy
- lactation
- subacute thyroiditis
Show all 10Show fewer
- postpartum thyroiditis
- abnormal liver function
- abnormal kidney function
- infectious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Xuzhou,
Xuzhou, Jiangsu, 221000
Zhen Zhongli, MD, +86 13952200973, 1973324055@qq.com
Xi Jijiang, MD, +86 13814429263, 549932860@qq.com
About this study
Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts on various levels of these components.
Recent evidence from HepG2 cells indicates that betatrophin, also known as TD26/RIFL/lipasin/ANGPTL8/C19orf80, a secreted protein that regulates glucose, lipid metabolism, and energy homeostasis, is induced by T3. However, the role of betatrophin in hyperthyroid patients is unknown.
The objective was to study serum betatrophin levels in hyperthyroid patients and the association of serum betatrophin levels with hyperthyroidism.
Read the detailed description
Thyroid hormone (TH) is a critical hormone responsible for growth, development, and metabolism. It maintains basal metabolic rate (BMR), improves adaptive thermogenesis, and thus modulates body weight by fine-tuning energy expenditure and intake. Hyperthyroidism, a condition with excess TH, presents a status of negative energy balance that is characterized by weight loss, increased energy expenditure, and accelerated lipolysis and gluconeogenesis. The mechanism underlying hypermetabolic status in hyperthyroidism is complicated. In hyperthyroidism, excess TH promotes the metabolism rate primarily by binding to TH receptor α or β, and in turn by further influencing diverse metabolic pathways. Recent studies have revealed that TH signals were involved in cross talk with a range of other metabolic signaling pathways in different metabolic organs. In liver, TH interacts with peroxisome proliferator-activated receptor (PPAR) α, PPARγ, and liver X receptor α pathway; promotes fatty acid oxidation; decreases cholesterol; and enhances gluconeogenesis. The elements required for TH action are well documented, but understanding the interaction between TH and various pathways remains a challenge.
Betatrophin, also known as TD26/RIFL/lipasin/ANGPTL8/C19orf80, is a novel protein predominantly expressed in human liver. Increasing evidence has revealed associations between betatrophin expression, glycemia and serum lipid profiles, particularly in patients with obesity or diabetes. Stimulators of betatrophin, such as insulin, thyroid hormone, irisin, SIRT1 and caloric intake, are usually relevant to energy expenditure or thermogenesis. A previous report revealed that betatrophin mRNA is induced by the thyroid hormone in HepG2 cells. Subsequent studies confirmed that transcriptional regulation is dependent on the thyroid hormone receptor that binds to the betatrophin upstream element. Therefore, betatrophin is a novel gene dramatically activated by the thyroid hormone. However, there is no evidence to date showing that TH is capable of regulating betatrophin expression in human beings. The current study investigated the change of betatrophin levels in patients with hyperthyroidism before and after thionamide treatment and explored the association of serum betatrophin levels with hyperthyroidism.
- Conditions
- Hyperthyroidism
- Being tested
- thionamide treatment for 3 months
- Keywords
- Hyperthyroidism, Betatrophin
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thionamide treatment for 3 monthsDrug
Also called methimazole, propylthiouracil, or propranolol
Hyperthyroid patients would received thionamide treatment (methimazole, propylthiouracil, or propranolol) for 3 months, and euthyroidism would be obtained.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroid Patients | Patients with hyperthyroidism Receives: Drug: thionamide treatment for 3 months | |
| NC group | Normal control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum betatrophin levels
Measured: Change from baseline at 3 months
Secondary outcomes (6)
Thyroid function index
Measured: At baseline and at the end of the third month
blood lipid profile
Measured: At baseline and at the end of the third month
liver function index
Measured: At baseline and at the end of the third month
hypersensitive c-reactive protein (hs-CRP)
Measured: At baseline and at the end of the third month
Blood glucose
Measured: At baseline and at the end of the third month
Serum insulin levels
Measured: At baseline and at the end of the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hu Hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hu Hao, The First People's Hospital of Xuzhou
- Investigators
- Wang Zhaoling, BD, Study chair, The First People's Hospital of XuzhouHu Hao, MD, Study director, The First People's Hospital of XuzhouGao Zhaohua, MD, Principal investigator, The First People's Hospital of XuzhouZhou Tingting, MD, Principal investigator, The First People's Hospital of XuzhouYin Wenwen, MD, Principal investigator, The First People's Hospital of XuzhouCai Ruonan, MD, Principal investigator, The First People's Hospital of Xuzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812888
- Sponsor's protocol ID
- FirstPHXuzhou
- Other IDs
- ChiCTR
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to the public upon completion of the study.
Publications
Lopez D, Abisambra Socarras JF, Bedi M, Ness GC. Activation of the hepatic LDL receptor promoter by thyroid hormone. Biochim Biophys Acta. 2007 Sep;1771(9):1216-25. doi: 10.1016/j.bbalip.2007.05.001. Epub 2007 May 21.
PubMed 17572141Ribeiro MO, Carvalho SD, Schultz JJ, Chiellini G, Scanlan TS, Bianco AC, Brent GA. Thyroid hormone--sympathetic interaction and adaptive thermogenesis are thyroid hormone receptor isoform--specific. J Clin Invest. 2001 Jul;108(1):97-105. doi: 10.1172/JCI12584.
PubMed 11435461Dong XY, Pang XW, Yu ST, Su YR, Wang HC, Yin YH, Wang YD, Chen WF. Identification of genes differentially expressed in human hepatocellular carcinoma by a modified suppression subtractive hybridization method. Int J Cancer. 2004 Nov 1;112(2):239-48. doi: 10.1002/ijc.20363.
PubMed 15352036Quagliarini F, Wang Y, Kozlitina J, Grishin NV, Hyde R, Boerwinkle E, Valenzuela DM, Murphy AJ, Cohen JC, Hobbs HH. Atypical angiopoietin-like protein that regulates ANGPTL3. Proc Natl Acad Sci U S A. 2012 Nov 27;109(48):19751-6. doi: 10.1073/pnas.1217552109. Epub 2012 Nov 12.
PubMed 23150577Ren G, Kim JY, Smas CM. Identification of RIFL, a novel adipocyte-enriched insulin target gene with a role in lipid metabolism. Am J Physiol Endocrinol Metab. 2012 Aug 1;303(3):E334-51. doi: 10.1152/ajpendo.00084.2012. Epub 2012 May 8.
PubMed 22569073Zhang R. Lipasin, a novel nutritionally-regulated liver-enriched factor that regulates serum triglyceride levels. Biochem Biophys Res Commun. 2012 Aug 10;424(4):786-92. doi: 10.1016/j.bbrc.2012.07.038. Epub 2012 Jul 15.
PubMed 22809513Yi P, Park JS, Melton DA. Betatrophin: a hormone that controls pancreatic beta cell proliferation. Cell. 2013 May 9;153(4):747-58. doi: 10.1016/j.cell.2013.04.008. Epub 2013 Apr 25.
PubMed 23623304Tseng YH, Ke PY, Liao CJ, Wu SM, Chi HC, Tsai CY, Chen CY, Lin YH, Lin KH. Chromosome 19 open reading frame 80 is upregulated by thyroid hormone and modulates autophagy and lipid metabolism. Autophagy. 2014 Jan;10(1):20-31. doi: 10.4161/auto.26126. Epub 2013 Nov 11.
PubMed 24262987
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Betatrophin Levels and Its Influencing Factors in Patients With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT02812888
- Acronym / sponsor ID
- FirstPHXuzhou
- Conditions
- Hyperthyroidism
- Keywords
- Hyperthyroidism, Betatrophin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hu HaoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- 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.
Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts on various levels of these components.
Recent evidence from HepG2 cells indicates that betatrophin, also known as TD26/RIFL/lipasin/ANGPTL8/C19orf80, a secreted protein that regulates glucose, lipid metabolism, and energy homeostasis, is induced by T3. However, the role of betatrophin in hyperthyroid patients is unknown.
The objective was to study serum betatrophin levels in hyperthyroid patients and the association of serum betatrophin levels with hyperthyroidism.
Detailed description
Thyroid hormone (TH) is a critical hormone responsible for growth, development, and metabolism. It maintains basal metabolic rate (BMR), improves adaptive thermogenesis, and thus modulates body weight by fine-tuning energy expenditure and intake. Hyperthyroidism, a condition with excess TH, presents a status of negative energy balance that is characterized by weight loss, increased energy expenditure, and accelerated lipolysis and gluconeogenesis. The mechanism underlying hypermetabolic status in hyperthyroidism is complicated. In hyperthyroidism, excess TH promotes the metabolism rate primarily by binding to TH receptor α or β, and in turn by further influencing diverse metabolic pathways. Recent studies have revealed that TH signals were involved in cross talk with a range of other metabolic signaling pathways in different metabolic organs. In liver, TH interacts with peroxisome proliferator-activated receptor (PPAR) α, PPARγ, and liver X receptor α pathway; promotes fatty acid oxidation; decreases cholesterol; and enhances gluconeogenesis. The elements required for TH action are well documented, but understanding the interaction between TH and various pathways remains a challenge.
Betatrophin, also known as TD26/RIFL/lipasin/ANGPTL8/C19orf80, is a novel protein predominantly expressed in human liver. Increasing evidence has revealed associations between betatrophin expression, glycemia and serum lipid profiles, particularly in patients with obesity or diabetes. Stimulators of betatrophin, such as insulin, thyroid hormone, irisin, SIRT1 and caloric intake, are usually relevant to energy expenditure or thermogenesis. A previous report revealed that betatrophin mRNA is induced by the thyroid hormone in HepG2 cells. Subsequent studies confirmed that transcriptional regulation is dependent on the thyroid hormone receptor that binds to the betatrophin upstream element. Therefore, betatrophin is a novel gene dramatically activated by the thyroid hormone. However, there is no evidence to date showing that TH is capable of regulating betatrophin expression in human beings. The current study investigated the change of betatrophin levels in patients with hyperthyroidism before and after thionamide treatment and explored the association of serum betatrophin levels with hyperthyroidism.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroid Patients | – | Drug: thionamide treatment for 3 monthsPatients with hyperthyroidism |
| NC group | – | –Normal control subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with hyperthyroidism would be recruited from the Department of Endocrinology, the First People's Hospital of Xuzhou, from May, 2016, to May, 2017. During the same period, the healthy controls would be selected.
Key inclusion criteria (2 listed)
- Clinical diagnosis of hyperthyroidism
- Must be drug-naive before recruitment
Key exclusion criteria (10 listed)
- diabetes
- hypertension
- cancer
- pregnancy
- lactation
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 |
|---|---|---|
| thionamide treatment for 3 monthsAlso: methimazole, propylthiouracil, or propranololHyperthyroid patients would received thionamide treatment (methimazole, propylthiouracil, or propranolol) for 3 months, and euthyroidism would be obtained. | Drug | Hyperthyroid Patients |
Primary outcome
Serum betatrophin levels
Time frame: Change from baseline at 3 months
6 secondary outcomes
Thyroid function index
Time frame: At baseline and at the end of the third month
blood lipid profile
Time frame: At baseline and at the end of the third month
liver function index
Time frame: At baseline and at the end of the third month
hypersensitive c-reactive protein (hs-CRP)
Time frame: At baseline and at the end of the third month
Blood glucose
Time frame: At baseline and at the end of the third month
Serum insulin levels
Time frame: At baseline and at the end of the third month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Background: PubMed 17572141Lopez D, Abisambra Socarras JF, Bedi M, Ness GC. Activation of the hepatic LDL receptor promoter by thyroid hormone. Biochim Biophys Acta. 2007 Sep;1771(9):1216-25. doi: 10.1016/j.bbalip.2007.05.001. Epub 2007 May 21.
- Background: PubMed 11435461Ribeiro MO, Carvalho SD, Schultz JJ, Chiellini G, Scanlan TS, Bianco AC, Brent GA. Thyroid hormone--sympathetic interaction and adaptive thermogenesis are thyroid hormone receptor isoform--specific. J Clin Invest. 2001 Jul;108(1):97-105. doi: 10.1172/JCI12584.
- Background: PubMed 15352036Dong XY, Pang XW, Yu ST, Su YR, Wang HC, Yin YH, Wang YD, Chen WF. Identification of genes differentially expressed in human hepatocellular carcinoma by a modified suppression subtractive hybridization method. Int J Cancer. 2004 Nov 1;112(2):239-48. doi: 10.1002/ijc.20363.
- Background: PubMed 23150577Quagliarini F, Wang Y, Kozlitina J, Grishin NV, Hyde R, Boerwinkle E, Valenzuela DM, Murphy AJ, Cohen JC, Hobbs HH. Atypical angiopoietin-like protein that regulates ANGPTL3. Proc Natl Acad Sci U S A. 2012 Nov 27;109(48):19751-6. doi: 10.1073/pnas.1217552109. Epub 2012 Nov 12.
- Background: PubMed 22569073Ren G, Kim JY, Smas CM. Identification of RIFL, a novel adipocyte-enriched insulin target gene with a role in lipid metabolism. Am J Physiol Endocrinol Metab. 2012 Aug 1;303(3):E334-51. doi: 10.1152/ajpendo.00084.2012. Epub 2012 May 8.
- Background: PubMed 22809513Zhang R. Lipasin, a novel nutritionally-regulated liver-enriched factor that regulates serum triglyceride levels. Biochem Biophys Res Commun. 2012 Aug 10;424(4):786-92. doi: 10.1016/j.bbrc.2012.07.038. Epub 2012 Jul 15.
- Background: PubMed 23623304Yi P, Park JS, Melton DA. Betatrophin: a hormone that controls pancreatic beta cell proliferation. Cell. 2013 May 9;153(4):747-58. doi: 10.1016/j.cell.2013.04.008. Epub 2013 Apr 25.
- Results publication: PubMed 24262987Tseng YH, Ke PY, Liao CJ, Wu SM, Chi HC, Tsai CY, Chen CY, Lin YH, Lin KH. Chromosome 19 open reading frame 80 is upregulated by thyroid hormone and modulates autophagy and lipid metabolism. Autophagy. 2014 Jan;10(1):20-31. doi: 10.4161/auto.26126. Epub 2013 Nov 11.
- test linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to the public upon completion of the study.
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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.
Wang Zhaoling, BD study chair
The First People's Hospital of Xuzhou
Hu Hao, MD study director
The First People's Hospital of Xuzhou
Gao Zhaohua, MD principal investigator
The First People's Hospital of Xuzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism, run by Hu Hao at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Hao, MD (+86 13685135953, 18361811955@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum betatrophin levels (time frame: Change from baseline at 3 months). 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 NCT02812888, which also lists 8 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 6 Jul 2016.