Effects of metformin on hepatic lipid metabolism

Effects of metformin on hepatic free fatty acid metabolism in type 2 diabetes asssessed by positron emission tomography

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000808-16-DK

Enrollment

Unknown

Registered

2013-03-22

Start date

2013-03-27

Completion date

Unknown

Last updated

2017-01-16

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

Conditions

Type 2 diabetes and dyslipidemia MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Metformin "Teva" Product Name: Metformin "Teva" Pharmaceutical Form: Coated tablet INN or Proposed INN: METFORMIN CAS Number: 657-24-9 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Group 1: Diabetes subjects: - newly diagnosed (>3 og =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - metformin treatment >6 months - Non-alcoholic steatohepatitis - Cancer - Anaemia - HbA1C>8.5 % - Other clinically meaningful abnormal biochemical parameter - Pancreatitis - Alcohol or substance abuse - Allergy towards metformin - Claustrophobia - Severe obesity >130 kg

Design outcomes

Primary

Measure	Time frame
Main Objective: It is the general purpose of the trial to investigate whether the positive effects of metformin on blood lipids are caused by improved glycemic control and changes in body composition or if they are caused by direct effects on lipid metabolism. We specifically plan to: - investigate hepatic fatty acid uptake, reesterification and oxidation assessed by positron emission tomography (PET) - investigate the effect of metformin on whole body VLDL-TG oxidation and redeposition in adipose tissue.;Secondary Objective: Not applicable;Primary end point(s): - hepatic FFA uptake ([11C]palmitate – PET technique) - hepatic FFA oxidation ([11C]palmitate – PET technique) - hepatic FFA reesterification ([11C]palmitate – PET technique) ;Timepoint(s) of evaluation of this end point: 3 months treatment	—

Measure

Time frame

Main Objective: It is the general purpose of the trial to investigate whether the positive effects of metformin on blood lipids are caused by improved glycemic control and changes in body composition or if they are caused by direct effects on lipid metabolism. We specifically plan to: - investigate hepatic fatty acid uptake, reesterification and oxidation assessed by positron emission tomography (PET) - investigate the effect of metformin on whole body VLDL-TG oxidation and redeposition in adipose tissue.;Secondary Objective: Not applicable;Primary end point(s): - hepatic FFA uptake ([11C]palmitate – PET technique) - hepatic FFA oxidation ([11C]palmitate – PET technique) - hepatic FFA reesterification ([11C]palmitate – PET technique) ;Timepoint(s) of evaluation of this end point: 3 months treatment

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Secondary

Measure	Time frame
Secondary end point(s): - VLDL-TG secretion ([14C]VLDL – isotope dilution technique) - VLDL-TG oxidation (14CO2 in breath) - VLDL-TG redeposition in adipose tissue. (fat biopsy ~ 1 g) - Insulin sensitivity in the liver and peripheral tissues [3H]glucose – isotope dilution technique - Body composition (DEXA) - Intracellular signalling in muscle and adipose tissue (AMPK, LKB1, ACC, CD36, ATGL, HSL, perilipin, G0S1, CGI58, GLUT4, og cytochrom C) ;Timepoint(s) of evaluation of this end point: 3 months treatment	—

Measure

Time frame

Secondary end point(s): - VLDL-TG secretion ([14C]VLDL – isotope dilution technique) - VLDL-TG oxidation (14CO2 in breath) - VLDL-TG redeposition in adipose tissue. (fat biopsy ~ 1 g) - Insulin sensitivity in the liver and peripheral tissues [3H]glucose – isotope dilution technique - Body composition (DEXA) - Intracellular signalling in muscle and adipose tissue (AMPK, LKB1, ACC, CD36, ATGL, HSL, perilipin, G0S1, CGI58, GLUT4, og cytochrom C) ;Timepoint(s) of evaluation of this end point: 3 months treatment

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Countries

Denmark

Contacts

Public ContactDepartment of Nuclear Medicine

Aarhus University Hospital

lars.christian.gormsen@ki.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026