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N-acetyl-cysteine and Insulin Sensitivity in PCOS

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ClinicalTrials.gov Identifier: NCT03902327
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Agata Chmurzyńska, Poznan University of Life Sciences

Brief Summary:
The effect of N-acetylcysteine supplementation on insulin resistance and homocysteine concentrations in women with polycystic ovary syndrome will be analysed.

Condition or disease Intervention/treatment Phase
Insulin Resistance Polycystic Ovary Syndrome Diet Habit Dietary Supplement: NAC group Dietary Supplement: Control group Dietary Supplement: Dietary group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trails
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does N-acetyl-cysteine Treatment Improves Insulin Sensitivity in Women With Polycystic Ovary Syndrome?
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
Placebo for 8 weeks, 4 pills per day; a diet based on general recommendations for people with insulin resistance
Dietary Supplement: Control group
Nutrition intervention focused on the treatment of insulin resistance + placebo (4 times a day) (30 people).

Experimental: NAC group
NAC for 8 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with insulin resistance
Dietary Supplement: NAC group
Nutrition intervention focused on the treatment of insulin resistance + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people).

Active Comparator: diet group
a diet based on general recommendations for people with insulin resistance
Dietary Supplement: Dietary group
Nutritional intervention focused on the treatment of insulin resistance (30 subjects).




Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 8 weeks ]
    Fasting insulin concentration (uU/ml) will be measured before and after 2 hours of 75g glucose drink. Insulin resistance will be measured before and after 8 weeks of the intervention.

  2. Oral glucose toletance test OGTT [ Time Frame: 8 weeks ]
    Fasting glucose concentration (mg/dL) will be measured before and after 2 hours of 75g glucose drink. OGTT test will be measured before and after 8 weeks of the intervention. Fasting glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance).

  3. Testosterone (ng/mL) [ Time Frame: 8 weeks ]
    Testosterone (ng/mL) concenrations will measured at baseline and after 8 weeks of the intervention

  4. SHBG (nmol/L) [ Time Frame: 8 weeks ]
    SHBG (nmol/L) concenrations will measured at baseline and after 8 weeks of the intervention

  5. DHEA-SO4 (umol/L) [ Time Frame: 8 weeks ]
    DHEA-SO4 (umol/L) concentrations will measured at baseline and after 8 weeks of the intervention.

  6. Antymullerian hormone AMH (ng/mL) [ Time Frame: 8 weeks ]
    AMH (ng/mL) concentrations will measured at baseline and after 8 weeks of the intervention.

  7. Free androgen index FAI [ Time Frame: 8 weeks ]
    Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).


Secondary Outcome Measures :
  1. Homocysteine concentrations mg/dL [ Time Frame: 8 weeks ]
    Plasma homocysteine concentrations at baseline and after 8 weeks of the intervention

  2. Glutathione level uM/L [ Time Frame: 8 weeks ]
    Plasma glutathione concentrations will be measured at baseline and after 8 weeks of the intervention

  3. Body weight kg [ Time Frame: 8 weeks ]
    Body weight will be assemsment at baseline and after 8 weeks of the intervention. Weight and height will be combined to report BMI in kg/m^2.

  4. Body height kg [ Time Frame: baseline ]
    Body height will be assemsment at baseline of the intervention.

  5. Body mass index kg/m2 [ Time Frame: 8 weeks ]
    BMI (body mass index kg/m2) will be assemsment at baseline and after 8 weeks of the intervention.

  6. Body composition [ Time Frame: 8 weeks ]
    Fat mass (%) and Fat free mass (%) will be assement at baseline and after 8 weeks of the intervention.

  7. MTHFR polymorphism [ Time Frame: baseline ]
    Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).

  8. Blood lipoproteins measured. [ Time Frame: 8 weeks ]
    Blood lipid profile: cholesterol mg/dL, low-density lipoprotein LDL mg/dL, high-density lipoprotein HDL mg/dL, triglycerides mg/dL will be measured at baseline and after 8 weeks of the intervention.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • patients diagnosed with PCOS and insulin resisatnce,
  • normal body weight (BMI: 18,5 - 24,9 kg/m2)
  • patients not participating in other similar research programs at the same time,
  • no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
  • written agreement to take part in the research.

Exclusion criteria:

  • the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
  • the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
  • failure to comply with dietary recommendations established during the nutritional intervention,
  • no history of clinical diagnosis of primary ovarian failure, hyperprolactinemia, Cushing's syndrome,
  • pregnancy and breast feeding.

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Responsible Party: Agata Chmurzyńska, dr hab, Director of Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03902327     History of Changes
Other Study ID Numbers: PoznanULS
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Agata Chmurzyńska, Poznan University of Life Sciences:
N - acetylocysteine
Polycystic Ovary Syndrome
insulin resistance
nutrition intervention
diet

Additional relevant MeSH terms:
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Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Acetylcysteine
N-monoacetylcystine
Hypoglycemic Agents
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents