Diabetes Mellitus, Type 2NCT03318913
Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus
A study testing Fish protein hydrolysates in people with Diabetes Mellitus, Type 2, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fish protein hydrolysates
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Oct 2017to 28 Mar 2018
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
Who cannot join
- History of symptomatic coronary artery disease;
- Stroke or other known atherosclerotic disease;
- Cancer;
- HIV positive;
- Alcohol or drug abuse within the past 6 months previous the visit 1;
- use any antioxidant supplementation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Macaé, Rio de Janeiro, 27979000
About this study
Official title: Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, Fish protein hydrolysates
- Keywords
- Vascular function, Type 2 diabetes mellitus, Fish protein hydrolysates
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
5g of the sucralose administered as white plastic capsules
Fish protein hydrolysatesOther
5g of the FPH dissolving in 100 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Health control | No intervention | Health young subjects free of diabetes mellitus and nutritional intervention |
| DM Placebo | Placebo comparator | Sucralose Receives: Other: Placebo |
| DM FHP | Active comparator | Fish protein hydrolysates Receives: Other: Fish protein hydrolysates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
macrovascular endothelial function
Measured: 60 min after nutritional intervention
Near infrared spectroscopy
microvascular endothelial function
Measured: 70 min after nutritional intervention
High performance liquid chromatography
serum amino acids
Measured: 75 min after nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start23 Oct 2017
- Primary completion15 Feb 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318913
- Sponsor's protocol ID
- 53392216.0.0000.5699
- Status last verified
- Dec 2019
- First submitted
- 18 Oct 2017
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects
- ClinicalTrials.gov ID
- NCT03318913
- Acronym / sponsor ID
- 53392216.0.0000.5699
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vascular function, Type 2 diabetes mellitus, Fish protein hydrolysates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 24 Oct 2017 (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.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health control | No intervention | –Health young subjects free of diabetes mellitus and nutritional intervention |
| DM Placebo | Placebo comparator | Other: PlaceboSucralose |
| DM FHP | Active comparator | Other: Fish protein hydrolysatesFish protein hydrolysates |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus
Key exclusion criteria (6 listed)
- History of symptomatic coronary artery disease;
- Stroke or other known atherosclerotic disease;
- Cancer;
- HIV positive;
- Alcohol or drug abuse within the past 6 months previous the visit 1;
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 |
|---|---|---|
| Placebo5g of the sucralose administered as white plastic capsules | Other | DM Placebo |
| Fish protein hydrolysates5g of the FPH dissolving in 100 mL of water | Other | DM FHP |
Primary outcome
Flow-mediated dilation
Time frame: 60 min after nutritional intervention
macrovascular endothelial function
Near infrared spectroscopy
Time frame: 70 min after nutritional intervention
microvascular endothelial function
High performance liquid chromatography
Time frame: 75 min after nutritional intervention
serum amino acids
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 13 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish protein hydrolysates in people with Diabetes Mellitus, Type 2, run by Universidade Federal do Rio de Janeiro 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 1 inclusion and 6 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 13 Dec 2019. 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.
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?
Flow-mediated dilation (time frame: 60 min after nutritional intervention). The study lists 3 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 13 Dec 2019.