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

• Register: ISRCTN
• Last refreshed on: 1 July 2019
• Main ID: ISRCTN59320820
• Date of registration: 04/12/2013
• Prospective Registration: No
• Primary sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)
• Public title: 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
• Scientific title: 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)
• Date of first enrolment: 21/12/2009
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN59320820
• Study type: Interventional
• Study design: Single centre non-randomised trial (Screening)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: James Illingworth

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 enter into the study and attend three visits for meal tests.

Interventions: meal tests with overnight and a 1-week course of acipimox treatment.
All the eligible participants (control, PCOS, and Diabetes) will have same three meal tests using the same protocol.
Each participant will have a 900 Kcal standardised meal test, at baseline, following overnight acipimox treatment (250mg at 8pm, 11pm and 6am), and following a week course of acipimox 250mg three times a day with an interval of a week between the meal tests. Participants will be asked to fast overnight from 8pm except water and attend the research centre at 8am. After taking the baseline blood samples and breath samples, a meal made of milk, cereals, cream, cheese and bread, and an emulsion with a small amount of carbon labelled fat (13C tripalmitic acid 10mg /kg body weight) will be provided. Blood samples and breath samples will be taken ½ hourly for first 3 hours and hourly for 3 hours through the inserted cannula at the forearm. Subjects will be asked to collect 4 more breath samples at home after the meal test. The breath test is simple and it is basically exhaling breath for a few seconds into a test tube using a plastic straw. The meal test will take 6 hours.

Primary Outcome(s)

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 Outcome(s)

Changes in lipid oxidation, exhaled 13CO2 AUC at 24 hour

Secondary ID(s)

N/A

Source(s) of Monetary Support

Diabetes charitable fund, The Hull and East Yorkshire Hospital NHS Trust and the University of Hull (UK)

Ethics review

Status:
Approval date:
Contact:

Hull and East Riding Research Ethics Committee, 19 November 2009, Reference Number: 09/H1304/72

Results

• Results available: Yes
• Date Completed: 31/12/2013