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

• ClinicalTrials.gov Identifier: NCT03902327
• Recruitment Status: Recruiting
• First Posted: April 4, 2019
• Last Update Posted: March 24, 2020
• Sponsor: Poznan University of Life Sciences
• Information provided by (Responsible Party): Agata Chmurzyńska, Poznan University of Life Sciences

Study Description

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

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

• 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
• Last Update Posted: March 24, 2020
• Last Verified: March 2020

• 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:

Insulin Resistance; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders