NCT02509858

Brief Summary

We investigated the effect of the administration of small doses of thyroxine to healthy humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake, insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment in the plasma membrane of monocytes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable diabetes-mellitus

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

February 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

5 years

First QC Date

July 26, 2015

Last Update Submit

July 27, 2015

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus, thyroxine

Outcome Measures

Primary Outcomes (1)

  • area under the glucose uptake versus time curve-AUC

    Muscle glucose uptake following meal ingestion

    Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal

Secondary Outcomes (16)

  • Plasma glucose levels following meal ingestion

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma insulin levels following meal ingestion

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma triglyceride levels following meal ingestion

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma total cholesterol levels following meal ingestion

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma LDL-cholesterol levels following meal ingestion

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • +11 more secondary outcomes

Study Arms (3)

thyroxine in eythyroid diabetics

ACTIVE COMPARATOR

50 μg of thyroxine once daily, for 2 months.

Drug: thyroxineOther: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)

thyroxine in euthyroid healthy humans

ACTIVE COMPARATOR

50 μg of thyroxine once daily, for 2 months.

Drug: thyroxineOther: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)

placebo in euthyroid diabetics

PLACEBO COMPARATOR

50 μg of placebo once daily, for 2 months.

Drug: PlaceboOther: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)

Interventions

thyroxineDRUG

treatment with 50μg of thyroxine once daily for two months.

Also known as: T4
thyroxine in euthyroid healthy humansthyroxine in eythyroid diabetics
PlaceboDRUG

treatment with 50μg of placebo, once daily, for two months.

placebo in euthyroid diabetics
A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)OTHER
placebo in euthyroid diabeticsthyroxine in euthyroid healthy humansthyroxine in eythyroid diabetics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy or treatment naive type 2 diabetes euthyroid subjects, with a micronodular texture of the thyroid gland.
  • Recreationally active
  • With stable body weight and diet during the last two months.

You may not qualify if:

  • Any systemic disease(besides glucose abnormalities)
  • Any medication therapy
  • Diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

ThyroxineCD36 AntigensProteins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPlatelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • GEORGE DIMITRIADIS, MD, Phd

    2nd Department of Internal Medicine, Research Institute and Diabetes Center, Athens University Medical School, Attikon Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of of Internal Medicine and Clinical Diabetology , University of Athens, Greece

Study Record Dates

First Submitted

July 26, 2015

First Posted

July 28, 2015

Study Start

February 1, 2009

Primary Completion

February 1, 2014

Study Completion

July 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07