Insulin ResistanceNCT03902327
N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women
A study testing NAC group in people with Insulin Resistance and Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Insulin Resistance, Obesity, Carbohydrate Metabolism Disorder
- What is being tested?
- NAC group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 17 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Sciences
Poznan, 60-624
Karolina Łagowska, PhD, +48618487335, karolina.lagowska@up.poznan.pl
About this study
Official title: Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
- Being tested
- NAC group, Control group
- Keywords
- N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC groupDietary supplement
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).
Control groupDietary supplement
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).
| Study group | Role | What they receive |
|---|---|---|
| NAC group | Experimental | NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder Receives: Dietary Supplement: NAC group |
| Control group | Active comparator | Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 weeks
Secondary outcomes (10)
Homocysteine concentrations mg/dL
Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention
Measured: 12 weeks
Glutathione level uM/L
Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention
Measured: 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.
Measured: 12 weeks
Body height kg
Body height will be assemsment at baseline of the intervention.
Measured: 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.
Measured: 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.
Measured: 12 weeks
MTHFR polymorphism
Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).
Measured: 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.
Measured: 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.
Measured: 12 weeks
C-Reactive Protein measured
C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start17 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trails
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agata Chmurzyńska, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902327
- Sponsor's protocol ID
- PoznanULS
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
- ClinicalTrials.gov ID
- NCT03902327
- Acronym / sponsor ID
- PoznanULS
- Keywords
- N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trails
| Arm | Type | Receives |
|---|---|---|
| NAC group | Experimental | Dietary Supplement: NAC groupNAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder |
| Control group | Active comparator | Dietary Supplement: Control groupPlacebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAC groupNutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people). | Dietary supplement | NAC group |
| Control groupNutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people). | Dietary supplement | Control group |
Primary outcome
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.
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).
10 secondary outcomes
Homocysteine concentrations mg/dL
Time frame: 12 weeks
Glutathione level uM/L
Time frame: 12 weeks
Body weight kg
Time frame: 12 weeks
Body height kg
Time frame: baseline
Body mass index kg/m2
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
MTHFR polymorphism
Time frame: baseline
Blood lipoproteins measured.
Time frame: 12 weeks
Cytokine measured
Time frame: 12 weeks
C-Reactive Protein measured
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAC group in people with Insulin Resistance and Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.