NCT02993562

Brief Summary

This project has the following primary aims: To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy Secondary aims are: To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

October 20, 2016

Last Update Submit

November 5, 2018

Conditions

Hypothyroidism

Keywords

Food intakeResting Energy ExpenditureGall Bladder emptyingInsulin responseBody Composition

Outcome Measures

Primary Outcomes (2)

  • Changes in food intake at ad libitum meal

    Changes in food intake at ad libitum meal measured at each experimental day

    6 months

  • Satiety

    Satiety measured on a visual analog score 13 times during each experimental day.

    6 months

Secondary Outcomes (16)

  • Changes in lean mass assessed through lean mass

    6 months

  • Changes in fat mass assessed through lean mass with DEXA-scan

    6 months

  • Changes in gall bladder emptying

    6 months

  • Changes in resting energy expenditure

    6 months

  • Changes in blood sugar response to standardized meal.

    6 Months

  • +11 more secondary outcomes

Study Arms (2)

Hypothyroid patients

Hypothyroid patients treated with Levothyroxine as part of normal treatment.

Drug: Levothyroxine

Healthy volunteers

Matched on age and BMI. 18 Persons.

Interventions

LevothyroxineDRUG

Normal treatment with levothyroxine.

Also known as: Eltroxin/Euthyrox
Hypothyroid patients

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18 Hypothyroid female patients with a TSH \> 10 without Levothyroxine treatment.

You may qualify if:

  • TSH \> 10
  • Female

You may not qualify if:

  • Competing serious disease
  • Male
  • Not able to understand written and spoken danish
  • Pregnancy
  • Thyroidectomized patients
  • Amiodarone treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research, Herlev and Gentofte Hospitals

Copenhagen, Capital Region, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Urine

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bjarke B Medici, MD

    Department of Internal Medicine, Herlev and Gentofte hospitals.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial Investigator

Study Record Dates

First Submitted

October 20, 2016

First Posted

December 15, 2016

Study Start

August 1, 2015

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)