N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women

Study Overview
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Brief Summary
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The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.

Official Title
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Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?

Conditions
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Insulin Resistance, Obesity, Carbohydrate Metabolism Disorder

Intervention / Treatment
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* Dietary Supplement: NAC group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: women diagnosed with carbohydrate metabolism disorder, obesity (BMI >29,9 kg/m2) patients not participating in other similar research programs at the same time, written agreement to take part in the research. Exclusion criteria: the use of medicament that may affect on carbohydrate metabolism within 4 weeks, failure to comply with dietary recommendations established during the nutritional intervention, pregnancy and breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trails
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC group<br>NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder | Dietary Supplement: NAC group<br>* Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people).<br>|
| Active Comparator: Control group<br>Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder | Dietary Supplement: Control group<br>* Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance | 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 12 weeks of the intervention. | 12 weeks | 
| Oral glucose toletance test OGTT | 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 12 weeks of the intervention. Fasting glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homocysteine concentrations mg/dL | Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention | 12 weeks | 
| Glutathione level uM/L | Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention | 12 weeks | 
| Body weight kg | Body weight will be assemsment at baseline and after 4,8 and12 weeks of the intervention. Weight and height will be combined to report BMI in kg/m^2. | 12 weeks | 
| Body height kg | Body height will be assemsment at baseline of the intervention. | baseline | 
| Body mass index kg/m2 | BMI (body mass index kg/m2) will be assemsment at baseline and after 4, 8 and 12 weeks of the intervention. | 12 weeks | 
| Body composition | Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention. | 12 weeks | 
| MTHFR polymorphism | Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention). | baseline | 
| Blood lipoproteins measured. | 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 12 weeks of the intervention. | 12 weeks | 
| Cytokine measured | Cytokine: IL-6 pg/ml, IL- 10 pg/ml, TNF - α pg/ml will be measured at baseline and after 12 weeks of the intervention. | 12 weeks | 
| C-Reactive Protein measured | C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism