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Glycocalyx Precursor

Endocalyx for Type 2 Diabetes

Phase 2 & 3

Waitlist Available

Led By Camila Margarita M Manrique Acevedo, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of T2D by a health care provider, confirmed by chart review

45-74 years of age at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to eight weeks assessment

Awards & highlights

Study Summary

This trial will test whether restoring the endothelial glycocalyx via dietary supplementation of glycocalyx precursors will potentiate vascular adaptations to exercise in Veterans with T2D.

Who is the study for?

This trial is for Veterans with Type 2 Diabetes who have an HbA1c between 6.5-9%, a fasting blood glucose under 200 mg/dL, and a BMI of 25-45 kg/m2. Participants should be sedentary, not vigorously active more than twice a week, and women must be postmenopausal. Exclusions include recent serious heart issues or stroke, heavy alcohol use, active cancer, severe kidney or liver disease, uncontrolled thyroid dysfunction or hypertension.Check my eligibility

What is being tested?

The study aims to see if taking Endocalyx (a dietary supplement) can improve how well the blood vessels function and adapt after exercise in people with Type 2 Diabetes by repairing the endothelial glycocalyx—a part of the blood vessel that's damaged by diabetes.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may relate to ingredients in Endocalyx such as glucosamine extract and others which could cause allergic reactions or digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 2 Diabetes by a doctor.

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I am between 45 and 74 years old.

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I have not had a menstrual period for at least one year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to eight weeks assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to eight weeks assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to eight weeks assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glygocalyx integrity - perfused boundary region

Secondary outcome measures

Structure of brachial artery

Structure of popliteal artery

Insulin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Dietary supplementation of glycocalyx precursors (DSGP)Experimental Treatment1 Intervention

Participants will daily ingest 3,712mg (i.e., six capsules) of DSGP for eight weeks. DSGP, commercially available as Endocalyx (Microvascular Health Solutions LLC, Alpine, UT), include glucosamine sulfate, fucoidan, superoxide dismutase, and high molecular weight hyaluronan.

Group II: PlaceboPlacebo Group1 Intervention

Participants will daily ingest 6 capsules daily of placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,409 Total Patients Enrolled

Camila Margarita M Manrique Acevedo, MDPrincipal InvestigatorHarry S. Truman Memorial, Columbia, MO

Media Library

Endocalyx (Glycocalyx Precursor) Clinical Trial Eligibility Overview. Trial Name: NCT05205005 — Phase 2 & 3

Type 2 Diabetes Research Study Groups: Dietary supplementation of glycocalyx precursors (DSGP), Placebo

Type 2 Diabetes Clinical Trial 2023: Endocalyx Highlights & Side Effects. Trial Name: NCT05205005 — Phase 2 & 3

Endocalyx (Glycocalyx Precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205005 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly citizens meet the requirements to participate in this experiment?

"For this particular study, the team is looking for middle-aged adults that fall between 45 to 64 years old. Out of the 3113 total clinical trials hosted on this website, 199 are geared towards children and 1122 are for seniors."

Answered by AI

Are we still taking in participants for this research project?

"The trial you are inquiring about is still recruiting patients, with the first posting on 5/25/2022 and the most recent update being from 5/27/2022."

Answered by AI

How many individuals will be enrolled in this clinical trial?

"That is accurate. The website clinicaltrials.gov has information showing that this trial is still looking for patients. This study was posted on May 25th, 2022 and updated two days later on the 27th. They are recruiting 24 people total from 1 location."

Answered by AI

Would I fit the profile of an ideal candidate for this research?

"Individuals between the ages of 45 and 64 who have type 2 diabetes mellitus may be eligible to participate in this clinical trial. The study is looking for around 24 people to enroll."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes

2022. "Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05205005.

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