Effects of Metformin on Hepatic FFA Metabolism

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-05-05

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Healthy controls

Healthy controls receiving 1000 mg metformin twice daily for 3 months

Group Type OTHER

Metformin

Intervention Type DRUG

1000 mg metformin twice daily in 3 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 tablets twice daily in 3 months

Metformin

Metformin "Sandoz", 1000 mg twice daily for 3 months

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

1000 mg metformin twice daily in 3 months

Interventions

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Metformin

1000 mg metformin twice daily in 3 months

Intervention Type DRUG

Placebo

2 tablets twice daily in 3 months

Intervention Type DRUG

Other Intervention Names

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Metformin "Sandoz" 500 mg

Eligibility Criteria

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Inclusion Criteria

* Recently diagnosed type 2 diabetes
* Age 50-70 years
* BMI\<40

Exclusion Criteria

* Insulin treatment
* NASH (non alcoholic steatohepatitis)
* Cancer
* Anemia
* HbA1C\>8.5 %
* Chronic or acute pancreatitis
* Alcohol or medicine abuse
* Allergy towards metformin
* Claustrophobia
* Severe obesity (weight \>130 kilogram)

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes