- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509858
The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, in Type 2 Diabetes Mellitus.
The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, at All Stages of Type 2 Diabetes Mellitus.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: thyroxine in eythyroid diabetics
50 μg of thyroxine once daily, for 2 months.
|
treatment with 50μg of thyroxine once daily for two months.
Other Names:
|
Active Comparator: thyroxine in euthyroid healthy humans
50 μg of thyroxine once daily, for 2 months.
|
treatment with 50μg of thyroxine once daily for two months.
Other Names:
|
Placebo Comparator: placebo in euthyroid diabetics
50 μg of placebo once daily, for 2 months.
|
treatment with 50μg of placebo, once daily, for two months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
area under the glucose uptake versus time curve-AUC
Time Frame: Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Muscle glucose uptake following meal ingestion
|
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma insulin levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma triglyceride levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma total cholesterol levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma LDL-cholesterol levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma HDL-cholesterol levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma Apo-A levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma Apo-B levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma Lp(α) levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma NEFA levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma glycerol levels following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Muscle blood flow following meal ingestion
Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
area under the plasma concentration versus time curve-AUC
|
0, 30, 60, 90, 120, 180, 240, 300 min postmeal
|
Plasma thyroid hormones
Time Frame: baseline
|
measure of plasma concentration
|
baseline
|
glucose uptake by peripheral monocytes by the usage of the fluorescent analogue 6-NBDG
Time Frame: baseline to 600 sec
|
area under the curve of 6-NBDG uptake by monocytes under insulin stimulation
|
baseline to 600 sec
|
% GLUT4 increment from baseline (0mU/l) to maximal concentration (200mU/l) of insulin.
Time Frame: baseline
|
baseline
|
|
Number of participants with adverse events
Time Frame: 300 min postmeal
|
300 min postmeal
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GEORGE DIMITRIADIS, MD, Phd, 2nd Department of Internal Medicine, Research Institute and Diabetes Center, Athens University Medical School, Attikon Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ΒΠΠΚ 50/11-02-09
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