Inflammation Reduction by TREhalose AdminisTration (IR-TREAT)

September 17, 2020 updated by: Amirhossein Sahebkar, Mashhad University of Medical Sciences

The Use of Intravenous Trehalose to Reduce Vascular Inflammation in Acute Coronary Syndrome

Arterial wall inflammation has been consistently suggested to serve a causal role in promoting atherosclerosis and predisposing to hard cardiovascular outcomes. Therefore, there is a global trend in the pharmaceutical industry to develop safe and effective anti-inflammatory agents that could lessen arterial wall inflammation and prevent its detrimental impact on atheroma growth and instability. To this end, autophagy has emerged as a key regulator of inflammation and dysfunctional autophagy machinery has been consistently reported as a contributing factor to atherosclerosis and inflammation. Trehalose, a natural disaccharide sugar found extensively among miscellaneous organisms, by preventing protein denaturation plays various protective roles against stress conditions. Numerous studies indicated trehalose's ability to induce macrophage autophagy-lysosomal biogenesis and reduce inflammation. Also, intravenous (IV) administration of trehalose showed beneficial effects in the reversal of atherosclerosis in atherosclerotic animals. Therefore, in this study, the investigators will explore the potential efficacy of IV trehalose administration on arterial inflammation by employing an positron emission tomography (PET) with 18F-labeled fluoro-2-deoxyglucose (18F-FDG) and computed tomography (18F-FDG PET/CT) technique which noninvasively characterizes vascular inflammation and atherosclerosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Razavi Khorasan
      • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9919991766
        • Recruiting
        • Ghaem Educational, Research and Treatment Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 18-55 years
  • Having a history of acute coronary syndrome
  • Having a baseline high-sensitivity C-reactive protein (hs-CRP) of ≥ 2mg/L
  • Willingness to participate in the trials.

Exclusion Criteria:

  • Lactation or breastfeeding
  • Diabetes mellitus
  • Nephrotic syndrome or Estimated Glomerular Filtration Rate (eGFR) < 30/mL/min/1.73m2
  • Active or recurrent hepatic disease or/and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) (ALT/AST) of > 3 times upper normal limit or total bilirubin of > 2 times upper normal limit
  • Active infectious or febrile disease
  • Any type of malignancy
  • History of transplantation
  • Consumption of immunosuppressive drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trehalose
Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks
Drug: Trehalose

Trehalose is a natural disaccharide sugar found extensively among miscellaneous organisms including bacteria, plants, insects, yeast, fungi, and invertebrates. By preventing protein denaturation, it plays various protective roles against stress conditions such as heat, freeze, oxidation, desiccation and dehydration. Owing to this capacity, trehalose is an FDA-approved pharmaceutical excipient that is used as a stabilizer in numerous medicines including parenteral products.

In this study, all injections will be conducted by a trained nurse in the presence of a specialist physician at a duration of 45-90 minutes.

Other Names:
  • Mycose
Placebo Comparator: Placebo
Participants will be received equal volume of normal saline weekly for a period of 12 weeks
Drug: Normal saline
A solution of 0.90% w/v of sodium chloride (NaCl) in water
Other Names:
  • Isotonic saline
  • Physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial wall inflammation in the aorta and carotid arteries
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
This will be assessed using the 18F-FDG PET/CT imaging technique
At the beginning and end of the intervention trial (Day 0 and week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid intima-media thickness (cIMT)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
This will be assessed using doppler sonography
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring beclin-1 to assess autophagy activation
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring high-sensitivity C-reactive protein (hs-CRP) to assess systemic inflammation
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring complete blood count (CBC) (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Assessing lipid profile (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
Including triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C)
At the beginning and end of the intervention trial (Day 0 and week 12)
Assessing glucose (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
Fasting blood glucose (FBS)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring thyroid-stimulating hormone (TSH) to assess thyroid function (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin (Bil) to assess liver function (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring creatinine (Cr), urine (Ur) and blood urea nitrogen (BUN) to assess renal function (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Evaluating electrocardiogram (ECG) and heart rhythm to assess heart function (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)
Measuring creatinine phosphokinase (CPK) to detect muscle damage (Safety)
Time Frame: At the beginning and end of the intervention trial (Day 0 and week 12)
At the beginning and end of the intervention trial (Day 0 and week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Anticipated)

May 20, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 964334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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