ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    resveratrol | Diabetes type 1
Previous Study | Return to List | Next Study

Estrogen and Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03436992
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryan Harris, Augusta University

Brief Summary:
Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Dietary Supplement: Antioxidant Cocktail Dietary Supplement: Resveratrol Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Estrogen-Mediated Impairments of Vascular Health in Diabetes
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid

Dietary Supplement: Resveratrol
270mg trans-resveratrol

Other: Placebo
placebo

No Intervention: Healthy control women
Healthy women who participate will receive no intervention and serve as controls.
Experimental: Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid

Dietary Supplement: Resveratrol
270mg trans-resveratrol

Other: Placebo
placebo




Primary Outcome Measures :
  1. Change in Flow-Mediated Dilation (FMD) [ Time Frame: change in FMD at 2hrs ]
    The change in FMD at ~2hrs from baseline values



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both men and premenopausal
  • Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
  • All races
  • Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion Criteria:

  • Clinical diagnosis of hepatic, cardiovascular, or renal disease
  • Uncontrolled Diabetes (HbA1c>9%)
  • Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
  • Proteinuria
  • Uncontrolled Hypertension (>140/90 mmHg on therapy)
  • Hormonal use of birth control (past 3 months)
  • Pregnancy
  • Oligomenorrhea
  • Direct vasoactive medications (i.e. nitrates)
  • Anti-estrogens (i.e. SERMs)
  • Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
  • Undetectable Anti-Mullerian Hormone (AMH) following screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436992


Contacts
Contact: Maire Rose Bieck, MS 706-721-5483 mbieck@augusta.edu
Contact: Ryan Harris, PhD, CES 706-721-5998 ryharris@augusta.edu

Locations
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Ryan A Harris, PhD    706-721-5998    ryharris@augusta.edu   
Georgia Prevention Institute Recruiting
Augusta, Georgia, United States, 30912
Contact: Ryan Harris, PhD, CES    706-721-5998    ryharris@augusta.edu   
Contact: Jacob Looney, BS    706-721-5483    jlooney@augusta.edu   
Sponsors and Collaborators
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ryan Harris, PhD, CES Augusta University

Responsible Party: Ryan Harris, Associate Professor, Augusta University
ClinicalTrials.gov Identifier: NCT03436992     History of Changes
Other Study ID Numbers: E2 and D
1R01HL137087-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan Harris, Augusta University:
Estrogen, Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Resveratrol
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Estrogens
Antioxidants
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents