Ketogenic Diet in PCOS With Obesity and Insulin Resistance
Condition: PCOS; Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

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 insulin resistance in obese and insulin resistant patients with Polycystic Ovary
      Syndrome
    

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 screening phase, patients from the clinic conforming to the inclusion
      criteria will be invited to participate in the anovulation screening phase, lasting up to 8
      weeks, during which measurements of LH, FSH, estradiol, progesterone and a gynecologic
      ultrasound will be done on 7th, 14th, 21st and 28th day of the presumed ovulatory cycle, or
      at any time if amenorrhea present. Consenting participants will provide written informed
      consent.

      Following the anovulation screening, the patients will be randomized in two arms of the
      study: 1. very low calorie ketogenic diet (VLCKD) and the 2. low calorie standard diet (LCD).

      The study is open label; thus, patients and investigators will not be blinded to treatment
      allocation due to the nature of the study intervention.

      The group assigned to the VLCKD will follow the VLCKD for 8 weeks, after which they will
      follow the LCD for the next 8 weeks.

      The group assigned to the LCD will follow the LCD for the entire length of the study (16
      weeks.)

      At the start of the study, after 8 weeks and after 16 weeks, following measurements and tests
      will be done:

        1. clinical examination with the measurement of height, body mass, circumference at the
           waist and hip level, arterial systolic and diastolic pressure, heart rate,
           Ferriman-Gallwey and videodermoscopic evaluation of hirsutism and bioimpedance body
           composition measurement;

        2. blood will be taken for: lipid profile, hepatic transaminases, fasting glucose, fasting
           insulin, HbA1c, potassium, sodium, urea, calcium, phosphorus, total proteins, albumins,
           total bilirubin, uric acid, complete blood count, sex hormone binding globulin (SHBG),
           liquid chromatography-mass spectrometry measurement of testosterone, androstenedione,
           DHEA, 17OH-progesterone, 17OH-pregnenolone;

        3. dietary interview;

        4. psychological evaluation using the following questionnaires: Symptom Questionnaire, the
           Psychosocial index and the Psychological Well-Being scales.
    

Intervention name(s): Very low calorie ketogenic diet; Low calorie standard diet
Intervention type(s): Combination Product; Behavioral
Intervention description(s): Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method; Low calorie standard diet with no specified dietary supplement addition
Other intervention name(s): Pronokal method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketogenic diet; Insulin resistance; PCOS; Obesity; Hyperandrogenism