Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus

Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus - Thyroid function and insulin sensitivity

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39459

Enrollment

Registered

2011-03-31

Start date

2011-07-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes hypothyroidism

Interventions

Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be metabolically characterized (

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or postmenopausal females - Age 40-65 years - Body mass index (BMI) 27 kg/m2 - Stable dietary habits (no weight loss/gain >3 kg in the last 6 months) - Stable physical activity levels for at least six months ;- Newly diagnosed hypothyroid, non-insulin dependent type 2 diabetic patients having TSH values higher then > 4.0 mU/l and lowered concentrations of free T4 100 IE/ml; Tg > 344 IE/ml), should have no auto-antibodies against glutamic acid decarboxylase (GAD), IA-2 and insulin to exclude type 2 polyglandular autoimmune syndrome (PGAII) (to exclude type 1 diabetes). - Type 2 diabetic patients should have a HbA1c level 27 kg/m2 - Stable dietary habits (no weight loss/gain >3 kg in the last 6 months) - Stable physical activity levels for at least six months ;- Newly diagnosed hypothyroid, patients having TSH values higher then > 4.0 mU/l (and lowered concentrations of free T4

Exclusion criteria

Exclusion criteria: - Unstable body weight - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study - Medical history including active cardiovascular disease, i.e. history of coronary artery disease (i.e. history of angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting) or cardiac arrhythmias. - Liver disease of liver dysfunction (ALT>2.5 x increased) - Impaired renalfunction (Kreat >100 umol/L) - Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg - Hb

Design outcomes

Primary

Measure	Time frame
For the diabetes-group: Thyroidhormone induced changes in insulin sensitivity and mitochondrial function of skeletal muscle. For the non-diabetic group: Thyroidhormone induced changes is brown adipose tissue activity.	—

Secondary

Measure	Time frame
Diabetics: Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown adipose tissue activity. Non-diabetics: thyroid hormone induced changes in energy expenditure.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)