Effect of lowering fatty acids levels with acipimox treatment on post-meal fat levels and insulin resistance in women with polycystic ovary syndrome and diabetes compared to healthy subjects

To determine if acute lowering of circulating non-esterified fatty acids (NEFAs) with acipimox improves postprandial hypertriglyceridaemia and insulin resistance in women with polycystic ovary syndrome (PCOS) and with type 2 diabetes mellitus (DM)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59320820

Enrollment

Registered

2013-12-04

Start date

2009-12-21

Completion date

Unknown

Last updated

2019-07-01

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

Conditions

Type 2 diabetes mellitus, polycystic ovary syndrome Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

An oral glucose tolerance test will be performed in women with PCOS and control subjects to exclude diabetes at screening. All the participants who fulfil the inclusion and exclusion criteria will ent

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: PCOS Arm: 1. Female 2. Age 18-45 year premenopausal 3. No history of diabetes 4. BMI 28-45 kg/m2 Diabetes arm: 1. Female 2. Age 18-45 year premenopausal 3. BMI 28-45 kg/m2 4. Type 2 Diabetes mellitus Healthy controls: 1. Female 2. Age 18-45 year premenopausal 3. BMI 28-45 kg/m2 4. No history of Diabetes or PCOS

Exclusion criteria

Exclusion criteria: 1. Pregnancy/breastfeeding 2. History of cardiovascular, renal, hepatic and thyroid disease 3. History of PCOS 4. History of allergy to acipimox 5. History of dyspepsia or peptic ulcers 6. History of food allergy 7. Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents 8. Unwilling for GP to be informed

Design outcomes

Primary

Measure	Time frame
1. Changes in HOMA-IR 2. Changes in fasting lipid profiles 3. Changes in fasting postprandial triglycerides, insulin secretion and glucose Measured at baseline and post acipimox treatment	—

Secondary

Measure	Time frame
Changes in lipid oxidation, exhaled 13CO2 AUC at 24 hour	—

Countries

United Kingdom

Outcome results

None listed

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