Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women

Charité University Medicine Berlin

Status: Completed

Conditions: Hyperandrogenism; Glucocorticoid Metabolism

Treatments: Drug: lipid/heparin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00473603

201-05

Details and patient eligibility

About

The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Full description

Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.

Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.

Enrollment: 13 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy men and women

Exclusion criteria

• diabetes mellitus or impaired glucose tolerance
• clinical signs of hyperandrogenism
• polycystic ovary
• hormonal therapy
• BMI > 30 kg/m2
• dysmenorrhoea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

LHI

Experimental group

Description:

to perform an i.v. lipid heparin infusion for 4 h

Treatment:

Drug: lipid/heparin infusion

SHI

Sham Comparator group

Description:

to perform an i.v. saline heparin infusion for 4 h

Treatment:

Drug: lipid/heparin infusion