search
Back to results

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

Primary Purpose

Insulin Resistance, Obesity, Carbohydrate Metabolism Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
NAC group
Control group
Sponsored by
Poznan University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Poznan University of Life SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAC group

Control group

Arm Description

NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder

Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Homocysteine concentrations mg/dL
Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention
Glutathione level uM/L
Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention
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.
Body height kg
Body height will be assemsment at baseline of the intervention.
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.
Body composition
Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention.
MTHFR polymorphism
Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).
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.
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.
C-Reactive Protein measured
C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention

Full Information

First Posted
March 11, 2019
Last Updated
March 23, 2020
Sponsor
Poznan University of Life Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03902327
Brief Title
N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women
Official Title
Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Carbohydrate Metabolism Disorder
Keywords
N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trails
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAC group
Arm Type
Experimental
Arm Description
NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder
Intervention Type
Dietary Supplement
Intervention Name(s)
NAC group
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
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.
Time Frame
12 weeks
Title
Oral glucose toletance test OGTT
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Homocysteine concentrations mg/dL
Description
Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention
Time Frame
12 weeks
Title
Glutathione level uM/L
Description
Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention
Time Frame
12 weeks
Title
Body weight kg
Description
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.
Time Frame
12 weeks
Title
Body height kg
Description
Body height will be assemsment at baseline of the intervention.
Time Frame
baseline
Title
Body mass index kg/m2
Description
BMI (body mass index kg/m2) will be assemsment at baseline and after 4, 8 and 12 weeks of the intervention.
Time Frame
12 weeks
Title
Body composition
Description
Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention.
Time Frame
12 weeks
Title
MTHFR polymorphism
Description
Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).
Time Frame
baseline
Title
Blood lipoproteins measured.
Description
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.
Time Frame
12 weeks
Title
Cytokine measured
Description
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.
Time Frame
12 weeks
Title
C-Reactive Protein measured
Description
C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznan
ZIP/Postal Code
60-624
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Łagowska, PhD
Phone
+48618487335
Email
karolina.lagowska@up.poznan.pl

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs