Diabetes MellitusNCT02509858
The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, in Type 2 Diabetes Mellitus.
A study testing thyroxine and A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) in people with Diabetes Mellitus, run by Attikon Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- thyroxine and A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any systemic disease(besides glucose abnormalities)
- Any medication therapy
- Diabetic complications
About this study
Official title: The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, at All Stages of Type 2 Diabetes Mellitus.
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.
Read the 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
- Being tested
- thyroxine, Placebo, A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)
- Keywords
- Diabetes mellitus, thyroxine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroxineDrug
Also called T4
treatment with 50μg of thyroxine once daily for two months.
PlaceboDrug
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)Other
| Study group | Role | What they receive |
|---|---|---|
| thyroxine in eythyroid diabetics | Active comparator | 50 μg of thyroxine once daily, for 2 months. Receives: Drug: thyroxine; Other: 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. Receives: Drug: thyroxine; Other: 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. Receives: Drug: Placebo; Other: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the glucose uptake versus time curve-AUC
Muscle glucose uptake following meal ingestion
Measured: Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Secondary outcomes (16)
Plasma glucose levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma insulin levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma triglyceride levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma total cholesterol levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma LDL-cholesterol levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma HDL-cholesterol levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma Apo-A levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma Apo-B levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma Lp(α) levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma NEFA levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma glycerol levels following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Muscle blood flow following meal ingestion
area under the plasma concentration versus time curve-AUC
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma thyroid hormones
measure of plasma concentration
Measured: baseline
glucose uptake by peripheral monocytes by the usage of the fluorescent analogue 6-NBDG
area under the curve of 6-NBDG uptake by monocytes under insulin stimulation
Measured: baseline to 600 sec
% GLUT4 increment from baseline (0mU/l) to maximal concentration (200mU/l) of insulin.
Measured: baseline
Number of participants with adverse events
Measured: 300 min postmeal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startFeb 2009
- Primary completionFeb 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
- Investigators
- GEORGE DIMITRIADIS, MD, Phd, Study director, 2nd Department of Internal Medicine, Research Institute and Diabetes Center, Athens University Medical School, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509858
- Sponsor's protocol ID
- ΒΠΠΚ 50/11-02-09
- Status last verified
- Jul 2015
- First submitted
- 26 Jul 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, at All Stages of Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT02509858
- Acronym / sponsor ID
- ΒΠΠΚ 50/11-02-09
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, thyroxine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thyroxine in eythyroid diabetics | Active comparator | Drug: thyroxine, Other: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)50 μg of thyroxine once daily, for 2 months. |
| thyroxine in euthyroid healthy humans | Active comparator | Drug: thyroxine, Other: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)50 μg of thyroxine once daily, for 2 months. |
| placebo in euthyroid diabetics | Placebo comparator | Drug: Placebo, Other: A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)50 μg of placebo once daily, for 2 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Any systemic disease(besides glucose abnormalities)
- Any medication therapy
- Diabetic complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroxineAlso: T4treatment with 50μg of thyroxine once daily for two months. | Drug | thyroxine in euthyroid healthy humans, thyroxine in eythyroid diabetics |
| Placebotreatment with 50μg of placebo, once daily, for two months. | Drug | placebo in euthyroid diabetics |
| A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) | Other | placebo in euthyroid diabetics, thyroxine in euthyroid healthy humans, thyroxine in eythyroid diabetics |
Primary outcome
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
16 secondary outcomes
Plasma glucose levels following meal ingestion
Time frame: 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
Plasma triglyceride levels following meal ingestion
Time frame: 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
Plasma LDL-cholesterol levels following meal ingestion
Time frame: 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
Plasma Apo-A levels following meal ingestion
Time frame: 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
Plasma Lp(α) levels following meal ingestion
Time frame: 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
Plasma glycerol levels following meal ingestion
Time frame: 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
Plasma thyroid hormones
Time frame: baseline
glucose uptake by peripheral monocytes by the usage of the fluorescent analogue 6-NBDG
Time frame: baseline to 600 sec
% GLUT4 increment from baseline (0mU/l) to maximal concentration (200mU/l) of insulin.
Time frame: baseline
Number of participants with adverse events
Time frame: 300 min postmeal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GEORGE DIMITRIADIS, MD, Phd study director
2nd Department of Internal Medicine, Research Institute and Diabetes Center, Athens University Medical School, Attikon Hospital
Questions about this trial
What is this clinical trial studying?
A study testing thyroxine and A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) in people with Diabetes Mellitus, run by Attikon Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the glucose uptake versus time curve-AUC (time frame: Time Frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.