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Abdominal Obesity Metabolic SyndromePhase 4GALANTA-MSNCT02283242

Galantamine Effects in Patients With Metabolic Syndrome

A Phase 4 study testing Galantamine in people with Abdominal Obesity Metabolic Syndrome, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is recognized that inflammation can be modulated by cholinergic stimulation and that galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action, has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement in tissue insulin resistance in animal models. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Abdominal Obesity Metabolic Syndrome
What is being tested?
Galantamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteBrazil
Study dates
Mar 2014to Feb 2017
Phase
Phase 4
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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of Metabolic Syndrome based on recently established criteria (three abnormal findings of the following five)
  • Increased abdominal circumference ≥ 102 cm for men and 90 cm for women
  • Low plasma level of HDL cholesterol < 40md/dL for men and 50 mg/dL for women
  • Increased values for plasma triglycerides > 150 mg/dL
  • Elevated blood pressure ≥130/85 mmHg
  • Elevated level of blood sugar value to 100 mg/dL
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  • Body Mass Index (BMI) between 25 and 39, with weight maintenance diet and stable for at least 6 months before study entry
  • Normal renal function and thyroid function
  • Able to participate in the study by signing an informed consent form and comply with study stages throughout its duration

Who cannot join

  • On use of antidiabetic medication
  • Triglyceride levels ≥ 400 mg/dL or use of lipid lowering medication
  • Levels of aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 200 U/L
  • Levels of aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 200 U/L
  • The office systemic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg at rest
  • BMI ≥ 40kg/m²
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  • In use of antihypertensive drugs that interfere with the heart rate variability
  • On the use of drugs that have known or probable interaction with galantamine: amitriptyline, fluoxetine, fluvoxamine, ketoconazole, oxybutynin, paroxetine, quinidine
  • Already participant in regular exercise programs, defined as 90 minutes of activity per week
  • Medical history, previous diagnosis or previous supplementary examinations indicating presence of cardiac arrhythmias, coronary artery disease, valvular disease, heart failure, chronic obstructive pulmonary disease, acute or chronic liver disease, renal insufficiency, thyroid disorders, chronic inflammatory diseases, cancer, positive status for HIV, other debilitating diseases
  • Abuse of alcohol or other substances in the 12 months prior to study entry
  • History of major depression or patients with suicidal ideation
  • Personal history of eating disorder
  • Utilization of drugs for obesity
  • Use of serotonin reuptake inhibitors
  • Pregnancy or desire to become pregnant during the study period

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of São Paulo, Heart Institute, Medical School

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: Effects of Cholinergic Stimulation on Visceral Fat, Oxidative Stress and Inflammatory Markers in Patients With Metabolic Syndrome: a Randomized Clinical Trial

It is recognized that inflammation can be modulated by cholinergic stimulation and that galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action, has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement in tissue insulin resistance in animal models. Galantamine is a safe drug that is used to treat alzheimer disease.Galantamine treatments of patients with the metabolic syndrome may represent a significant advance in management of this disease. This study aims to investigate the effects of galantamine on inflammatory markers, as well as on abdominal visceral and epicardial fat and oxidative stress in patients with metabolic syndrome. This is a pioneering study that will include expert support. The enrolling of subjects will have continuous monitoring throughout the period of treatment. The study is a double blind randomized prospective study with 60 patients with metabolic syndrome, to be randomized at ratio of 1: 1 placebo and galantamine. The dose of galanthamine is the standard clinically approved (8 and 16 mg). The tracking method include metabolic analysis, inflammatory and oxidative stress markers, hemodynamic evaluation with hear rate variability (sympatho vagal modulation) before, during and after treatment. Computerized tomography assessment of visceral abdominal and epicardial fat before and after treatment will be performed.

Read the detailed description

Population: patients with metabolic syndrome; Intervention: Galantamine; Comparation: Placebo; Outcomes (primary): proinflammatory cytokines levels.

Description:

Patients with criteria of Metabolic Syndrome (with the 2005 revised NCEP ATP III criteria) will be randomized to 2 groups: use of galantamina (30 patients) or placebo (30 patients) in the following sequency:

  1. 4 weeks of treatment with 8 mg of galantamine or placedo (oral ingestion capsules);

II) 8 weeks of treatment with 16 mg of galantamine or placebo (oral ingestion capsules).

Participants will receive a diary to record any symptoms that may present and will be instructed to bring it at each study visit.

Before randomization all participants will go through the following procedures:

  • Clinical and neurological evaluation;
  • Blood sample analysis of cytokines, oxidative stress and biochemical parameters;
  • Multidetector computed tomographic (MDCT) scan of abdomen (visceral - abdominal and epicardial fat) and thorax (calcium score);
  • blood pressure recording for hemodynamic evaluation and assessment of heart rate variability
  • 24h ambulatory blood pressure measurement

These procedures will be repeated at the end of the protocol.

This is a randomized controlled trial study. Blinding status: Patients, investigators, and outcome assessors.

All participants were outpatients.

The invitation to participate in the study and all the details of the protocol will be explained.

Once the patients have the criteria for inclusion, they receive the cards with capsules containing placebo or galantamine according to continuous numerical order provided by the pharmacy that prepared and randomized such substances (numbered containers).

Drug and placebo will be manipulated and encapsulated in identical packaging at the Central Pharmacy of School of Medicine, University of São Paulo.

We will use simple randomisation using a randomisation table created by computer software - graphpad Software- quickcalcs.

Being tested
Galantamine, Placebo (for galantamine)
Keywords
Cholinergic Antagonists, Inflammation, Oxidative Stress
Medical subject headings
Abdominal obesity metabolic syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalantamineDrug

    Also called Reminyl ER

    Oral use for 12 weeks

  • Placebo (for galantamine)Drug

    Also called Placebo

    Oral use for 12 weeks

Study groups in NCT02283242
Study groupRoleWhat they receive
GalantamineExperimental* 8 mg of Galantamine for 4 weeks * 16 mg Galantamine for 8 weeks
Receives: Drug: Galantamine
PlaceboPlacebo comparator* 8 mg of placebo for 4 weeks * 16 mg placebo for 8 weeks
Receives: Drug: Placebo (for galantamine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin

    Measured: 12 weeks

Secondary outcomes (6)

  1. Glucose, triglycerides and high density lipoprotein cholesterol levels

    Measured: 12 weeks

  2. Insulin levels

    Measured: 12 weeks

  3. Arterial blood pressure levels

    Measured: 12 weeks

  4. Heart Rate Variability

    Measured: 12 weeks

  5. Composite measure of markers of oxidative stress, to include: total amount of free radicals, malondialdehyde, allantoin, anpha-1-antiproteinase, oxidize/reduced glutatione ratio

    Measured: 12 weeks

  6. Abdominal fat levels

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2015
  4. Study completionFeb 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283242
Sponsor's protocol ID
CAAE:27386114.9.0000.0068
Other IDs
2013/22250-9
Acronym
GALANTA-MS
Status last verified
Feb 2017
First submitted
7 Oct 2014
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Consolim-Colombo FM, Sangaleti CT, Costa FO, Morais TL, Lopes HF, Motta JM, Irigoyen MC, Bortoloto LA, Rochitte CE, Harris YT, Satapathy SK, Olofsson PS, Akerman M, Chavan SS, MacKay M, Barnaby DP, Lesser ML, Roth J, Tracey KJ, Pavlov VA. Galantamine alleviates inflammation and insulin resistance in patients with metabolic syndrome in a randomized trial. JCI Insight. 2017 Jul 20;2(14):e93340. doi: 10.1172/jci.insight.93340. eCollection 2017 Jul 20.

    PubMed 28724799

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Galantamine in people with Abdominal Obesity Metabolic Syndrome, run by University of Sao Paulo at 1 site in Brazil.

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 9 inclusion and 16 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: finished, as of the sponsor's last update on 15 Feb 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283242, which also lists 1 linked publication.

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 15 Feb 2017.

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