Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Placebo; Other: Fish protein hydrolysates

• Registration Number: NCT03318913
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study Start: 2017-10-23
• Study First Posted: 2017-10-24
• Primary Completion: 2018-02-15
• Study Completion: 2018-03-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Type 2 diabetes mellitus

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DM Placebo	Placebo	Sucralose
DM FHP	Fish protein hydrolysates	Fish protein hydrolysates

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation	60 min after nutritional intervention	macrovascular endothelial function
Near infrared spectroscopy	70 min after nutritional intervention	microvascular endothelial function
High performance liquid chromatography	75 min after nutritional intervention	serum amino acids

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Macaé, Rio De Janeiro, Brazil