Clinical trial NCT02416960: Effect of the Glycemic Index of Diet on Metabolic and Reproductive Parameters in Overweight and Obese Infertile Women
Official title: Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Infertility
Obesity
Keywords: female infertility
glycemic index
leptin
ghrelin
overweight
obesity
in vitro fertilization
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-04-15
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. The patients who meet the inclusion criteria and accept to participate in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment.

Detailed description: Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. Infertile women with grade I and II obesity, or pre-obesity with increased waist circumference will be recruited. Patients will be assigned to Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet), and will follow the protocol for 12 weeks. The two intervention diets will be similar in terms of caloric intake and macronutrient distribution and different in terms of carbohydrates quality (index and glycemic load). Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment. Before and after the intervention anthropometric measurements (weight, height, body mass index, waist and hip circumference) and body composition (body fat percentage determined by the measurement of seven skinfolds) will be evaluated as well as biochemical parameters: leptin, acylated ghrelin, glucose, insulin, serum lipids (total cholesterol and lipoproteins, and triglycerides), sex hormones - follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, testosterone and sex hormone binding globulin (SHBG). Primary outcome: clinical pregnancy rate. Secondary outcomes: HOMA-IR (Homeostasis Model Assessment), acylated ghrelin and leptin levels, body fat percentage, number of oocytes retrieved, percentage of fertilized oocytes and embryo quality.

Eligibility criteria: Inclusion Criteria:

* Diagnose of female infertility and indication for treatment with in vitro fertilization
* Body Mass Index (BMI) equal or greater than 30 kg/m² or BMI \> 25 kg/m² with increased waist circumference (\> 80 cm);
* Being not treated (diet) for weight loss/gain and maintaining stable body weight in the three months prior to the study;
* Not having stomach/digestive problems
* Not having the knowledge of cardiovascular disease history;
* Non-smokers;
* Not using any medication.

Exclusion Criteria:

* Patients with BMI equal or higher than 40 kg/m² (morbid obesity)
* Patients who are already receiving some type of nutritional intervention
* Patients with co-morbidities that may interfere with reproductive capacity (genetic and/or endocrine disorders, diabetes mellitus, cancer, liver or kidney failure), alcoholics, individuals who have contact (work) with heavy metals or chemicals (exposure to solvents and pesticides)
* Lack of adherence to the proposed dietary treatment

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle
Secondary outcomes:
measure: HOMA-IR index (Homeostasis Model Assessment)
timeFrame: baseline and 12 weeks
measure: Acylated Ghrelin Levels (pg/dL)
timeFrame: baseline and 12 weeks
measure: Leptin Levels (ng/mL)
timeFrame: baseline and 12 weeks
measure: Body Fat Percentage (%)
timeFrame: baseline and 12 weeks
measure: Number of Oocytes Retrieved
timeFrame: between 12 and 16 weeks, during the in vitro fertilization cycle
measure: Percentage of Fertilized Oocytes (%)
timeFrame: between 12 and 16 weeks, during the in vitro fertilization cycle
measure: Embryo Quality
timeFrame: between 12 and 16 weeks, during the in vitro fertilization cycle
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: UFRGS/HCPA
name: Cileide C Moulin, PhD
role: PRINCIPAL_INVESTIGATOR
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