NCT03318913

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

October 18, 2017

Last Update Submit

December 11, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

Vascular functionType 2 diabetes mellitusFish protein hydrolysates

Outcome Measures

Primary Outcomes (3)

  • Flow-mediated dilation

    macrovascular endothelial function

    60 min after nutritional intervention

  • Near infrared spectroscopy

    microvascular endothelial function

    70 min after nutritional intervention

  • High performance liquid chromatography

    serum amino acids

    75 min after nutritional intervention

Study Arms (3)

Health control

NO INTERVENTION

Health young subjects free of diabetes mellitus and nutritional intervention

DM Placebo

PLACEBO COMPARATOR

Sucralose

Other: Placebo

DM FHP

ACTIVE COMPARATOR

Fish protein hydrolysates

Other: Fish protein hydrolysates

Interventions

PlaceboOTHER

5g of the sucralose administered as white plastic capsules

DM Placebo
Fish protein hydrolysatesOTHER

5g of the FPH dissolving in 100 mL of water

DM FHP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Macaé, Rio de Janeiro, 27979000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
D.sc

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

October 23, 2017

Primary Completion

February 15, 2018

Study Completion

March 28, 2018

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

BR(1)