Metabolic SyndromePhase 2GC-NASHNCT01553500
Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease
A Phase 2 study testing glucomannan and lifestyle intervention in people with Metabolic Syndrome and Non Alcoholic Fatty Liver Disease, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Metabolic Syndrome, Non Alcoholic Fatty Liver Disease, Insulin Resistance
- What is being tested?
- glucomannan and lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Dec 2013
- Phase
- Phase 2
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- informed consent by parents or legal tutor
- ALT levels <10 ULN
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- INR < 1,3
- Albumin > 3 g/dl
- total bilirubin < 2,5 mg/dl
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- no previous gastrointestinal bleeding
- no previous portosystemic encephalopathy
- normal renal function
- no HIV-HCV-HDV infection
- normal cell blood count
Who cannot join
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
- corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- finding of actual or previous level of alpha-fetoprotein > 50 ng/ml
- hepatocellular carcinoma
- diabetes mellitus type I
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.
Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.
Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.
- Being tested
- glucomannan, lifestyle intervention
- Keywords
- NAFLD, insulin resistance, children
- Medical subject headings
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucomannanDietary supplement
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
lifestyle interventionBehavioural
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
| Study group | Role | What they receive |
|---|---|---|
| glucomannan | Experimental | Not described Receives: Dietary Supplement: glucomannan |
| placebo | Placebo comparator | Not described Receives: Behavioral: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in lipid profile
Evaluation of tryglicerides, total and LDL colesterol levels
Measured: 6,12,18,24 months
Change from baseline in glycemic homeostasis
glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test
Measured: 6,12,18,24 months
Secondary outcomes (1)
liver enzymes
evaluation of liver function test
Measured: 6,12,18,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerio Nobili, Bambino Gesù Hospital and Research Institute
- Investigators
- Valerio Nobili, MD, Principal investigator, Bambino Gesù Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553500
- Sponsor's protocol ID
- OPBG_GLUCO_2010
- Acronym
- GC-NASH
- Status last verified
- Mar 2012
- First submitted
- 3 Oct 2011
- Last updated
- 2 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
- ClinicalTrials.gov ID
- NCT01553500
- Acronym / sponsor ID
- GC-NASH / OPBG_GLUCO_2010
- Keywords
- NAFLD, insulin resistance, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Mar 2012 (estimated)
- 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.
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.
Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.
Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucomannan | Experimental | Dietary Supplement: glucomannan |
| placebo | Placebo comparator | Behavioral: lifestyle intervention |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- informed consent by parents or legal tutor
- ALT levels <10 ULN
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- INR < 1,3
- Albumin > 3 g/dl
Key exclusion criteria (8 listed)
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
- corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
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 |
|---|---|---|
| glucomannanglucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day) | Dietary supplement | glucomannan |
| lifestyle interventionhypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity | Behavioural | placebo |
Primary outcome
Change from Baseline in lipid profile
Time frame: 6,12,18,24 months
Evaluation of tryglicerides, total and LDL colesterol levels
Change from baseline in glycemic homeostasis
Time frame: 6,12,18,24 months
glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test
1 secondary outcome
liver enzymes
Time frame: 6,12,18,24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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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.
Valerio Nobili, MD principal investigator
Bambino Gesù Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucomannan and lifestyle intervention in people with Metabolic Syndrome and Non Alcoholic Fatty Liver Disease, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 11 inclusion and 8 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 2 Apr 2014. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in lipid profile (time frame: 6,12,18,24 months). 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 2 Apr 2014.