The Role of Thyroid Status in Regulating Brown Adipose Tissue Activity, White Adipose Tissue Partitioning and Resting Energy Expenditure

NCT03064542 | Completed

• 1 other identifier: 2015/00718
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine how thyroid status regulates the relationship between brown adipose tissue (BAT) volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in hyperthyroid patients transitioning to euthyroidism via antithyroid drugs. To compare euthyroid outcomes (BAT, WAT, BMR, body composition, body weight and insulin resistance) achieved by hypothalamus-pituitary-thyroid (HPT) set point vs. normal ranges of plasma free thyroxine 4 (FT4) and throxine stimulating hormone (TSH).

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (1)

• Thyroid function test (serum free thyroxine (FT4) and serum thyroid stimulating hormone (TSH).

  This observation supports the concept of a unique set point in FT4 and TSH for any given individual and forms the basis for optimization of thyroid status by targeting the FT4 and TSH levels towards the set point. All data, study and clinical endpoints will be analyzed and correlated by the proximity of the final stable euthyroid Thyroid function test (TFT) to the predicted euthyroid set point using the computer software.

  6 months of treatment with an anti-thyroid drug

Secondary Outcomes (5)

• Fat volume- Brown adipose tissue (BAT)

  6 months of treatment with an anti-thyroid drug

• Fat volume- White adipose tissue (WAT)

  6 months of treatment with an anti-thyroid drug

• Energy expenditure

  6 months of treatment with an anti-thyroid drug

• Body composition

  6 months of treatment with an anti-thyroid drug

• Infrared thermography (IRT)

  6 months of treatment with an anti-thyroid drug

Interventions

carbimazole (CMZ) or thiamazole (TMZ) DRUG

CMZ or TMZ will be used to treat the hyperthyroidism till the FT4/TSH is in normal range.

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hyperthyroid patients diagnosed with Graves' disease

You may qualify if:

• You must be aged 21 to 50 years old (no gender restrictions).
• You must be diagnosed with Graves' disease.
• You are able to give informed consent..
• You must have body mass index (BMI) between 18.5 to 29.9 kg/m2 inclusive.
• You must be treated with carbimazole (CMZ) or thiamazole (TMZ) and compliant to treatment.
• Willing to avail yourself for the whole study and follow study procedures.

You may not qualify if:

• Chronic illnesses such as diabetes mellitus or cancer.
• You have a known history of liver or kidney disease.
• Female subjects who are pregnant or contemplating pregnancy.
• Those allergic to carbimazole (CMZ) or thiamazole (TMZ).
• History of surgery with metallic clips, staples or stents.
• Those on drugs that might affect body composition (eg. steroids) or BAT (eg. beta-blockers).
• Those with poor compliance to medication.
• Presence of cardiac pacemaker or other foreign body in any part of the body.
• History of claustrophobia particularly in a MRI scanner.
• Those with a history of bronchial asthma.
• Those with overt congestive heart failure.

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

Tan Tock Seng Hospital, Endocrinology Clinic

Singapore, 308433, Singapore

Location

Related Publications (1)

• Sun L, Goh HJ, Verma S, Govindharajulu P, Sadananthan SA, Michael N, Henry CJ, Goh JP, Velan SS, Leow MK. Brown adipose tissues mediate the metabolism of branched chain amino acids during the transitioning from hyperthyroidism to euthyroidism (TRIBUTE). Sci Rep. 2022 Mar 7;12(1):3693. doi: 10.1038/s41598-022-07701-7.

  PMID: 35256693 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for thyroid function, liver and kidney function, fasting glucose, insulin and lipids, analysis of fat metabolism and protein profiles. Urine samples for fat metabolism and protein profiles.

MeSH Terms

Conditions

Hyperthyroidism

Interventions

Carbimazole; Methimazole

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 27, 2017
• Study Start: October 13, 2015
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)