Trial Outcomes & Findings for Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes (NCT NCT05205005)
NCT ID: NCT05205005
Last Updated: 2025-05-02
Results Overview
Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity.
COMPLETED
PHASE2/PHASE3
24 participants
Change from baseline to eight weeks assessment
2025-05-02
Participant Flow
This clinical trial is a proof of concept clinical trial phase that corresponds to Aim 1 of a larger project. The participants assigned to intervention in this trial completed either the DSGP supplementation or placebo arms. No aim 2/clinical trial phase 2 will be enacted for the larger project.
Participant milestones
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=12 Participants
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 Participants
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to eight weeks assessmentPopulation: participants that completed full study intervention with baseline and eight week assessment.
Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity.
Outcome measures
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=10 Participants
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 Participants
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Glygocalyx Integrity - Perfused Boundary Region
|
0.11 Delta micrometers (mcm)
Standard Error 0.17
|
-0.16 Delta micrometers (mcm)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and final assessment (Week 8)Population: participants that completed full study intervention with baseline and eight week assessment.
Arterial measurements will be performed by imaging the brachial artery artery longitudinally using high-resolution duplex ultrasonography. Arterial vasodilatory responses to hyperemia (flow-mediated dilation; FMD) will be examined by inflating a cuff up to 250 mmHg for five minutes. Before, during and after rapid release of the cuff, brachial artery blood flow velocity and diameter will be continuously measured. This is a measurement of endothelial function. When assessing FMD, the cuff will squeeze the arm tightly; however, any discomfort will be alleviated as soon as the pressure in the cuff is released.
Outcome measures
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=10 Participants
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 Participants
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Brachial Artery Flow Mediated Dilation
Baseline
|
2.93 FMD %
Standard Error 0.39
|
2.14 FMD %
Standard Error 0.27
|
|
Brachial Artery Flow Mediated Dilation
Final
|
3.20 FMD %
Standard Error 0.47
|
1.87 FMD %
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline and final assessment (Week 8)Population: participants that completed full study intervention with baseline and eight week assessment.
Insulin-stimulated leg blood flow will be assessed via Doppler and contrast-enhanced ultrasound during an insulin-dextrose clamp. After a minimum of 20 minutes in supine rest, baseline cardiovascular measurements will be collected, including Doppler and contrast-enhanced ultrasound-based measures, blood samples obtained and then the insulin clamp will start. Briefly, insulin (Humulin R U-100) will be infused via IV at a constant rate of 80mU/m2 body surface area/min for the three-hour period. Blood glucose will be measured at five-minute intervals and maintained at fasting levels; this will be achieved by variable IV infusion rates of a 20% dextrose solution. The measurements described will allow for the assessment of the insulin stimulated leg blood flow
Outcome measures
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=10 Participants
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 Participants
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Insulin-stimulated Leg Blood Flow
Baseline
|
5.98 mL/min
Standard Error 11.92
|
16.93 mL/min
Standard Error 15.38
|
|
Insulin-stimulated Leg Blood Flow
Final
|
2.97 mL/min
Standard Error 12.14
|
9.55 mL/min
Standard Error 9.03
|
SECONDARY outcome
Timeframe: Baseline and final assessment (Week 8)Population: participants that completed full study intervention with baseline and eight week assessment.
Arterial measurements will be performed by imaging the femoral artery longitudinally using high-resolution duplex ultrasonography. Arterial vasodilatory responses to hyperemia (flow-mediated dilation; FMD) will be examined by inflating a cuff up to 250 mmHg for five minutes. Before, during and after rapid release of the cuff, femoral artery blood flow velocity and diameter will be continuously measured (these are used to calculate the FMD). This is a measurement of endothelial function. When assessing FMD, the cuff will squeeze the leg tightly; however, any discomfort will be alleviated as soon as the pressure in the cuff is released.
Outcome measures
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=10 Participants
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 Participants
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Femoral Artery Flow Mediated Dilation
Baseline
|
2.93 FMD %
Standard Error 0.39
|
2.14 FMD %
Standard Error 0.27
|
|
Femoral Artery Flow Mediated Dilation
Final
|
3.20 FMD %
Standard Error 0.47
|
1.87 FMD %
Standard Error 0.34
|
Adverse Events
Dietary Supplementation of Glycocalyx Precursors (DSGP)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dietary Supplementation of Glycocalyx Precursors (DSGP)
n=12 participants at risk
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.
Endocalyx: 3,712mg (six capsules) of DSGP for eight weeks.
|
Placebo
n=12 participants at risk
Participants will daily ingest 6 capsules daily of placebo for eight weeks.
Placebo: Ingredients per capsule (6 capsules per day) Nu-Mag Nat 10.00mg Rice Flour White 830 mg Magnesium Stearate 10.00mg
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tendon injury
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
|
Gastrointestinal disorders
Loose stools
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
|
Gastrointestinal disorders
Stomach Ache
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
|
Blood and lymphatic system disorders
PT/PTT lab elevation
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
1/12 • Number of events 1 • Screening visit until final assessment (week 8 assessment)
|
0.00%
0/12 • Screening visit until final assessment (week 8 assessment)
|
Additional Information
Harry S. Truman Memorial Veterans' Hospital Research Service
Harry S. Truman Memorial Veterans' Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place