Insulin Resistance, Polycystic Ovary Syndrome
Conditions
Brief summary
The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
Detailed description
After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle. Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose. Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction. After data collection, statistical analyses was done to determine the effect of the different approaches.
Interventions
BEHAVIORALTime restricted eating
Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.
Sponsors
Centro Medico ABC
Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age: 20 - 35 years * Mild to moderate exercise at least 4 times per week * Body Mass Index (BMI) of 20-24.9 * Diagnosis of PCOS by Rotterdam criteria * Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2. * PCOS Phenotype A, B, C * nulliparity * Signed informed consent letter
Exclusion criteria
* Menopause or perimenopause * Night work shifts * Phenotype D (without hyperandrogenism) * Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases. * Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCOS Rotterdam criteria | 3 months | Ovary volume \>9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance (IR) | 3 months | HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance |
Countries
Mexico
Outcome results
None listed