Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

NCT02891668 | Completed DMC

• 1 other identifier: Herlev-Hymaq
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This project has the following primary aims: The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment. Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).

Conditions

Hypothyroidism

Keywords

Basal Metabolic rate; Quality of life; Resting energy expenditure; Insulin resistance; Cognitive Function; Body Composition

Outcome Measures

Primary Outcomes (2)

• Changes in quality of life as measured with the ThyPro questionaire

  1 year

• Changes in resting energy expenditure in KCal/day

  1 year

Secondary Outcomes (10)

• Changes in Perceived Deficit Questionaire

  1 year

• Changes in insulin resistance evaluated by MATSUDA index

  1 year

• Changes in insulin resistance evaluated by HOMA index

  1 year

• Changes in cognitive tests

  1 year

• Changes in body composition asses through lean mass

  1 year

Study Arms (2)

Hypothyroid

Levothyroxine treatment

Drug: Levothyroxine treatment

Healthy volunteers

Matched on age and BMI 18 persons

Interventions

Levothyroxine treatment DRUG

Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.

Also known as: Eltroxin, Euthyrox

Hypothyroid

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypothyroid patients.

You may qualify if:

• TSH \> 10 mU/liter

You may not qualify if:

• Serious competing illness
• Pregnancy or planning to become pregnant
• Thyroidectomized patients
• Unable to speak and understand danish

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of internal Medicine, Herlev Hospital

Herlev, Capital Region, DK-2730, Denmark

Location

Related Publications (1)

• Medici BB, Lerche la Cour J, Knop FK, Krakauer M, Michaelsson LF, Faber J, Watt T, Nygaard B. Predictors of Improvement in Quality of Life When Treating Hypothyroidism. J Thyroid Res. 2021 Jun 11;2021:5577217. doi: 10.1155/2021/5577217. eCollection 2021.

  PMID: 34194721 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hypothyroidism; Insulin Resistance

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bjarke Medici, MD

  Bjarke Medici

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PH.d. student

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: September 7, 2016
• Study Start: May 1, 2015
• Primary Completion: May 20, 2018
• Study Completion: May 20, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

DK (1)