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OpenTrials
Completed

NCT Number: NCT03318913

Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro

Macaé, Rio de Janeiro, 27979000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Other

5g of the sucralose administered as white plastic capsules

Fish protein hydrolysates

Other

5g of the FPH dissolving in 100 mL of water

Primary outcomes

  1. Flow-mediated dilation

    Time frame: 60 min after nutritional intervention

    macrovascular endothelial function

  2. Near infrared spectroscopy

    Time frame: 70 min after nutritional intervention

    microvascular endothelial function

  3. High performance liquid chromatography

    Time frame: 75 min after nutritional intervention

    serum amino acids

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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