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Serum Betatrophin Levels and Its Influencing Factors in Patients With Hyperthyroidism

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ClinicalTrials.gov Identifier: NCT02812888
Recruitment Status : Unknown
Verified July 2016 by Hu Hao, The First People's Hospital of Xuzhou.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Hu Hao, The First People's Hospital of Xuzhou

Brief 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.

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.


Condition or disease Intervention/treatment
Hyperthyroidism Drug: thionamide treatment for 3 months

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: Serum Betatrophin Levels and Its Influencing Factors in Patients With Hyperthyroidism
Study Start Date : July 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism

Group/Cohort Intervention/treatment
Hyperthyroid Patients
Patients with hyperthyroidism
Drug: thionamide treatment for 3 months
Hyperthyroid patients would received thionamide treatment (methimazole, propylthiouracil, or propranolol) for 3 months, and euthyroidism would be obtained.
Other Name: methimazole, propylthiouracil, or propranolol

NC group
Normal control subjects



Primary Outcome Measures :
  1. Serum betatrophin levels [ Time Frame: Change from baseline at 3 months ]

Secondary Outcome Measures :
  1. Thyroid function index [ Time Frame: At baseline and at the end of the third month ]
  2. blood lipid profile [ Time Frame: At baseline and at the end of the third month ]
  3. liver function index [ Time Frame: At baseline and at the end of the third month ]
  4. hypersensitive c-reactive protein (hs-CRP) [ Time Frame: At baseline and at the end of the third month ]
  5. Blood glucose [ Time Frame: At baseline and at the end of the third month ]
  6. Serum insulin levels [ Time Frame: At baseline and at the end of the third month ]

Biospecimen Retention:   Samples Without DNA
Plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of hyperthyroidism
  • Must be drug-naive before recruitment

Exclusion Criteria:

  • diabetes
  • hypertension
  • cancer
  • pregnancy
  • lactation
  • subacute thyroiditis
  • postpartum thyroiditis
  • abnormal liver function
  • abnormal kidney function
  • infectious diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812888


Contacts
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Contact: Hu Hao, MD +86 13685135953 18361811955@163.com
Contact: Wang Zhaoling, BD +86 13852103069 dyywzl@126.com

Locations
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China, Jiangsu
The First People's Hospital of Xuzhou, Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Zhen Zhongli, MD    +86 13952200973    1973324055@qq.com   
Contact: Xi Jijiang, MD    +86 13814429263    549932860@qq.com   
Sponsors and Collaborators
Hu Hao
Investigators
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Study Chair: Wang Zhaoling, BD The First People's Hospital of Xuzhou
Study Director: Hu Hao, MD The First People's Hospital of Xuzhou
Principal Investigator: Gao Zhaohua, MD The First People's Hospital of Xuzhou
Principal Investigator: Zhou Tingting, MD The First People's Hospital of Xuzhou
Principal Investigator: Yin Wenwen, MD The First People's Hospital of Xuzhou
Principal Investigator: Cai Ruonan, MD The First People's Hospital of Xuzhou
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Using network platform: https://www.opendrive.com/ username: 18361811955@163.com password: woaini1314 The repository and management of the data can be obtained via "Public Folder".

Publications of Results:
Other Publications:

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Responsible Party: Hu Hao, Deputy Director, Department of endocrinology, Principal Investigator, Clinical Associate Professor, The First People's Hospital of Xuzhou
ClinicalTrials.gov Identifier: NCT02812888    
Other Study ID Numbers: FirstPHXuzhou
ChiCTR ( Registry Identifier: 16008506 )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by Hu Hao, The First People's Hospital of Xuzhou:
Hyperthyroidism
Betatrophin
Additional relevant MeSH terms:
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Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Propranolol
Methimazole
Propylthiouracil
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimetabolites