The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, in Type 2 Diabetes Mellitus.

NCT ID: NCT02509858

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2015-07-31

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.

Detailed Description

The present open-labeled, randomized and placebo-controlled study was undertaken in euthyroid type 2 diabetic patients and healthy humans, to examine the effect of administration of small doses of thyroxine within the euthyroid range, on muscle glucose disposal, postprandial insulin sensitivity, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment in the plasma membrane of monocytes.This was investigated with the arteriovenous-difference technique after the consumption of a mixed meal and the in vitro study of a glucose analogue(6-NBDG) uptake by the peripheral monocytes.

Subjects and Methods: Eleven euthyroid, treatment naive, type-2 diabetic patients with a micronodular texture of the thyroid gland and eleven healthy euthyroid subjects, were studied before and after administration of 50 μg of thyroxine once daily for 2 months. In parallel, a placebo group was also studied. Eleven euthyroid treatment-naïve subjects with type 2 diabetes and a micronodular texture of the thyroid gland, matched for age, sex, BMI, and basal thyroid function, were studied before and after administration of a placebo, once daily for 2 months.

Experimental protocol: All subjects were admitted to the hospital at 0700 h after an overnight fast and had the radial artery (A) and a forearm deep vein (V) catheterized. A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) was given at least 1 h after catheter insertion and was consumed within 20 min. Blood samples were drawn from both sites before the meal (at -30 and 0 min) and at 30- to 60-min intervals for 300 min thereafter for measurements of thyroid hormones,glucose, total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides, Apolipoprotein A1, Apolipoprotein BII and Lp(a).Forearm blood flow was measured with strain-gauge plethysmography. After the first meal tolerance test, treatment with 50μg of thyroxine or placebo, once daily, was initiated for a 2-month period. Then a second identical test was repeated. Special care was taken in order to avoid the induction of subclinical hyperthyroidism, that is suppression of TSH below 0.27 μU/ml, as it has recently been shown that the latter is also an insulin-resistant condition.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

thyroxine in eythyroid diabetics

50 μg of thyroxine once daily, for 2 months.

Group Type: ACTIVE_COMPARATOR

thyroxine

Intervention Type: DRUG

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

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

Intervention Type: OTHER

thyroxine in euthyroid healthy humans

50 μg of thyroxine once daily, for 2 months.

Group Type: ACTIVE_COMPARATOR

thyroxine

Intervention Type: DRUG

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

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

Intervention Type: OTHER

placebo in euthyroid diabetics

50 μg of placebo once daily, for 2 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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

Intervention Type: OTHER

Interventions

thyroxine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

T4

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

VAIA LAMBADIARI

Assistant Professor of of Internal Medicine and Clinical Diabetology , University of Athens, Greece

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GEORGE DIMITRIADIS, MD, Phd

Role: STUDY_DIRECTOR

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

Other Identifiers

ΒΠΠΚ 50/11-02-09

Identifier Type: -

Identifier Source: org_study_id