NCT02812888

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

June 20, 2016

Last Update Submit

July 5, 2016

Conditions

Keywords

HyperthyroidismBetatrophin

Outcome Measures

Primary Outcomes (1)

  • Serum betatrophin levels

    Change from baseline at 3 months

Secondary Outcomes (6)

  • Thyroid function index

    At baseline and at the end of the third month

  • blood lipid profile

    At baseline and at the end of the third month

  • liver function index

    At baseline and at the end of the third month

  • hypersensitive c-reactive protein (hs-CRP)

    At baseline and at the end of the third month

  • Blood glucose

    At baseline and at the end of the third month

  • +1 more secondary outcomes

Study Arms (2)

Hyperthyroid Patients

Patients with hyperthyroidism

Drug: thionamide treatment for 3 months

NC group

Normal control subjects

Interventions

Hyperthyroid patients would received thionamide treatment (methimazole, propylthiouracil, or propranolol) for 3 months, and euthyroidism would be obtained.

Also known as: methimazole, propylthiouracil, or propranolol
Hyperthyroid Patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Xuzhou,

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 17572141BACKGROUND
  • Ribeiro 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.

    PMID: 11435461BACKGROUND
  • Dong 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.

    PMID: 15352036BACKGROUND
  • Quagliarini 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.

    PMID: 23150577BACKGROUND
  • Ren 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.

    PMID: 22569073BACKGROUND
  • Zhang 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.

    PMID: 22809513BACKGROUND
  • Yi 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.

    PMID: 23623304BACKGROUND
  • Tseng 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Hyperthyroidism

Interventions

MethimazolePropylthiouracilPropranolol

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl CompoundsSulfur CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiouracilUracilPyrimidinonesPyrimidinesPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Wang Zhaoling, BD

    The First People's Hospital of Xuzhou

    STUDY CHAIR
  • Hu Hao, MD

    The First People's Hospital of Xuzhou

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director, Department of endocrinology, Principal Investigator, Clinical Associate Professor

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 24, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Individual Participant Data Set Access

Locations