Status:
COMPLETED
Ketogenic Diet in PCOS With Obesity and Insulin Resistance
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Pronokal group
Conditions:
PCOS
Obesity
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insuli...
Detailed Description
Consecutive patients coming to the Endocrinology and Diabetes Clinic of the S.Orsola hospital in Bologna with the suspicion of PCOS, during the study period, will be eligible to participate. In the sc...
Eligibility Criteria
Inclusion
- PCOS according to the NIH criteria;
- Body mass index (BMI) between 30 and 35 kg/m3;
- HOMA index ≥ 3 (according to formula: (fasting glucose \[mmol/L\] × fasting insulin \[mIU/L\])/22.5)
- Written informed consent.
Exclusion
- Diabetes type 1
- Exogenous insulin or insulin analogue therapy
- Obesity caused by endocrine disease other than PCOS
- Obesity caused by pharmacotherapy
- Use of a weight-loss diet in the past 3 months
- Use of contraceptive pills in the past 3 months
- Severe depression
- Other psychiatric diseases
- Alcohol or psychoactive substance abuse
- Severe hepatic insufficiency
- Renal calculosis
- Renal insufficiency
- Episodes of gout
- Malignant neoplasia
- Previous cardiovascular or cerebrovascular events
- Uncontrolled hypertension
- Water-electrolyte imbalance
- Any pharmacotherapy capable of interfering with glucose metabolism
- Any pharmacotherapy capable of interfering with steroid metabolism
- Menopause
- Pregnancy
- Lactation.
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04801173
Start Date
March 2 2021
End Date
December 6 2021
Last Update
January 27 2022
Active Locations (1)
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1
Unit of Endocrinology and Prevention and Care of Diabetes, S.Orsola Hospital
Bologna, Italy, 40138