Phase 4 N=36 Randomized Double-blind Basic Science

Effects of Metformin on Hepatic FFA Metabolism

Type 2 Diabetes · Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT01729156 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Hepatic Fatty Acid Oxidation — 0.052; 0.045; 0.042 micromol/ml/min

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Metformin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Lars Christian Gormsen
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Hepatic Fatty Acid Oxidation	0.052; 0.045; 0.042	—
PRIMARY Hepatic Fatty Acid Reesterification	0.134; 0.091; 0.113	—
PRIMARY Hepatic Fatty Acid Uptake	0.186; 0.137; 0.155	—
PRIMARY VLDL-TG Secretion	48; 83; 71	—
PRIMARY Whole Body Glucose Rd	1.74; 1.30; 1.78	—
SECONDARY Fatty Acid Turnover	464; 476; 559	—
SECONDARY VLDL-TG Oxidation	29; 30; 27	—

Summary

Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism. Whereas there is general agreement that the blood glucose lowering effect of metformin results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug lowers blood triglyceride concentration. There are indications that it enhances hepatic free fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily accessible for sampling in humans and data on the clinical effects of metformin in the liver are therefore lacking. This may change due to the increasing use of the positron emission tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling. Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes. Design: Randomized, placebo controlled, double-blind parallel study with patients receiving either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals will receive metformin for 3 months. Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing hepatic fatty acid oxidation

Eligibility Criteria

Inclusion Criteria

Recently diagnosed type 2 diabetes
Age 50-70 years
BMI 8.5 %
Chronic or acute pancreatitis
Alcohol or medicine abuse
Allergy towards metformin
Claustrophobia
Severe obesity (weight >130 kilogram)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01729156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.