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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902327
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Agata Chmurzyńska, Poznan University of Life Sciences

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

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Carbohydrate Metabolism Disorder Dietary Supplement: NAC group Dietary Supplement: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 Carbohydrate Metabolism in Obese Women?
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NAC group
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
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).

Active Comparator: Control group
Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder
Dietary Supplement: Control group
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).




Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 12 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 12 weeks of the intervention.

  2. Oral glucose toletance test OGTT [ Time Frame: 12 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 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).


Secondary Outcome Measures :
  1. Homocysteine concentrations mg/dL [ Time Frame: 12 weeks ]
    Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention

  2. Glutathione level uM/L [ Time Frame: 12 weeks ]
    Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention

  3. Body weight kg [ Time Frame: 12 weeks ]
    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.

  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: 12 weeks ]
    BMI (body mass index kg/m2) will be assemsment at baseline and after 4, 8 and 12 weeks of the intervention.

  6. Body composition [ Time Frame: 12 weeks ]
    Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 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: 12 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 12 weeks of the intervention.

  9. Cytokine measured [ Time Frame: 12 weeks ]
    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.

  10. C-Reactive Protein measured [ Time Frame: 12 weeks ]
    C-Reactive Protein will be measured at baseline and after 12 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902327


Locations
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Poland
Poznan University of Life Sciences Recruiting
Poznan, Poland, 60-624
Contact: Karolina Łagowska, PhD    +48618487335    karolina.lagowska@up.poznan.pl   
Sponsors and Collaborators
Poznan University of Life Sciences
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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    
Other Study ID Numbers: PoznanULS
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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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
Obesity
Insulin resistance
Nutrition intervention
Carbohydrate Metabolism
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders