NCT04449198

Brief Summary

The proposed study is designed to test the hypothesis that treatment of resveratrol for 12 weeks will improve both endothelin-B receptor (aim 1) and skeletal muscle mitochondrial function (aim 2) in people with type 1 diabetes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
14mo left

Started Oct 2020

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2020Jul 2027

First Submitted

Initial submission to the registry

June 11, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 14, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

6.2 years

First QC Date

June 11, 2020

Last Update Submit

January 27, 2025

Conditions

Type 1 Diabetes

Keywords

diabetesheart diseasemuscle functionblood vessels

Outcome Measures

Primary Outcomes (2)

  • Change in AUC for ET-1 + BQ-123

    Change in Area Under the Curve (AUC) for Cutaneous Vascular Conductance (CVC) in response to co-perfusion of ET-1 + BQ-123 at 12 weeks. Measured using intradermal microdialysis technique in conjunction with Laser Speckle Contrast Imaging (Moor FLPI-2) and beat-by-beat blood pressure monitoring (Finapres NOVA).

    Measure taken at Baseline and post 12 weeks

  • Skeletal Muscle Mitochondrial Function

    Change in Skeletal Muscle Mitochondrial Function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1)

    Measure taken at Baseline and post 12 weeks

Secondary Outcomes (3)

  • Change in Percentage Flow-Mediated Dilation (FMD)

    Measure taken at Baseline and post 12 weeks

  • Change in Pulse Wave Velocity (PWV)

    Measure taken at Baseline and post 12 weeks

  • Change in Post Occlusive Reactive Hyperemia (PORH)

    Baseline and post 12 weeks

Study Arms (2)

Individuals with type 1 diabetes

EXPERIMENTAL

Individuals with type 1 diabetes will be randomly assigned to 1 of the 2 interventions (Resveratrol or placebo)

Drug: ResveratrolOther: Placebo

Healthy Controls

NO INTERVENTION

Healthy individuals who participate will receive no intervention and serve as controls.

Interventions

ResveratrolDRUG

500 mg of oral trans-resveratrol twice daily (in the morning and evening) for 12-weeks

Individuals with type 1 diabetes
PlaceboOTHER

placebo for 12 weeks

Individuals with type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and premenopausal women
  • All races
  • Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

You may not qualify if:

  • Clinical diagnosis of hepatic, cardiovascular, or renal disease
  • Uncontrolled diabetes (HbA1C \>12%)
  • Diabetic complications (i.e. neuropathy)
  • Uncontrolled hypertension (\>140/90 mm Hg on therapy)
  • Pregnancy
  • Use of vasoactive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology

Augusta, Georgia, 30912, United States

RECRUITING

Related Publications (1)

  • Derella CC, Thomas J, Harris RA. Women Have Greater Endothelin-B Receptor Function and Lower Mitochondrial Capacity Compared to Men With Type 1 Diabetes. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2561-2568. doi: 10.1210/clinem/dgad189.

    PMID: 37009678DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusHeart Diseases

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Central Study Contacts

Ryan A Harris, PhD, CEP

CONTACT

7067215998ryharris@augusta.edu

Jacob Looney, MS

CONTACT

7067215483jlooney@augusta.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 26, 2020

Study Start

October 14, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

US(1)