Effect of exercise on lipid challenged insulin resistance and cardiovascular risk markers in PolyCystic Ovary Syndrome (PCOS)

Testing the hypothesis of metabolic competence in polycystic ovary syndrome

Registry ID
ISRCTN42448814
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Hull and East Yorkshire Hospitals NHS Trust (UK)
Enrollment
48
Start date
2010-10-17
Completion date
2014-10-01
Last update
2026-08-17

Conditions

Summary

Polycystic ovary syndrome

Detailed description

The participants who fulfil the inclusion and exclusion criteria will be recruited for the study. All the participants will undergo two day procedures of either saline or intralipid infusion for 5 hours with the measurement of insulin sensitivity in the last two hours of infusion by a hyperinsulinaemic euglycaemic clamp. Briefly, following a 12 hour overnight fast, subjects will attend the research centre at 8am for the infusion test. A cannula will be inserted in the elbow for the test infusions as per protocol. Another cannula will be placed into the other forearm vein for blood sampling. This arm will be wrapped with a blanket (60 deg C) in a heating box to be able to measure the reliable blood glucose. An infusion either saline or intralipid with heparin will be given for first three hours and it will be followed by two hours of glucose/ insulin infusions to measure the rate of glucose disposal by the muscles (insulin sensitivity). A drop of blood will be taken for plasma glucose measurements every 5 minutes throughout 120 minutes. Blood samples will be collected every hour for 5 hours. The same procedures will be repeated at the end of the exercise program. Participants will be asked to attend the Department of Sport, Health and Exercise Science at the University of Hull to complete the VO2max test and receive 8 week exercise prescription. The VO2max test is an exercise test that will be performed on a motorised treadmill. The exercise program is 3 sessions (aiming 60 minutes in each session) per week, moderate intensity for 8 weeks. The performance and attendance will be supervised by the sports specialists from University of Hull. At the end of the program, the repeat measurement of VO2max will be conducted on the treadmill.

Interventions

Inclusion criteria

1. Age 18-40 year premenopausal women 2. For lean participants BMI 18-25 kg/m2 3. For obese participants 26-40 kg/m2 4. The absence or presence of polycystic ovary syndrome (evidence of anovulation/oligomenorrhoea, clinical or biochemical hyperandrogenism, polycystic ovaries on ultrasound scanning which meets the PCOS diagnostic criteria of Rotterdam consensus statement) for controls and women with PCOS respectively

Exclusion criteria

1. Pregnancy/breastfeeding/trying to conceive 2. History of cardiovascular, renal, hepatic and thyroid disease 3. History of physical disability to exercise 4. History of diabetes mellitus 5. History of allergy to insulin/ soy oil, purified egg (intralipid) 6. Currently on oral anti-diabetic medication that improves insulin sensitivity such as metformin, weight reduction medication (orlistat, sibutramine) 7. Family history of sudden death 8. History of regular exercise three times a week for the last three months 9. Unwilling to be informed to their GP about their participation

Locations

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