Serum Betatrophin Levels and Its Influencing Factors in Patients With Hyperthyroidism

July 5, 2016 updated by: Hu Hao

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wang Zhaoling, BD
  • Phone Number: +86 13852103069
  • Email: dyywzl@126.com

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The First People's Hospital of Xuzhou,
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • methimazole, propylthiouracil, or propranolol
NC group
Normal control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum betatrophin levels
Time Frame: Change from baseline at 3 months
Change from baseline at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Thyroid function index
Time Frame: At baseline and at the end of the third month
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
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
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
At baseline and at the end of the third month
Blood glucose
Time Frame: At baseline and at the end of the third month
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
At baseline and at the end of the third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hu Hao

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstPHXuzhou
  • ChiCTR (REGISTRY: 16008506)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: 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".

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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