Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus

NCT00762671 | Completed Phase 2 DMC

• 1 other identifier: 1999-P-003331Ebselen
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn how blood vessel function is altered by diabetes. We are studying an investigational drug, Ebselen, to see if it can improve the ability of blood vessels to relax (widen).

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Endothelium-dependent and endothelium-independent vasodilation of peripheral resistance and conduit vessels will be studied in diabetic (type 1 and 2) and healthy subjects two weeks following randomization to the ebselen or placebo.

  one testing visit every 4 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

1

ACTIVE COMPARATOR

Ebselen

Drug: Ebselen

Interventions

Ebselen DRUG

150 mg BID for 2 weeks

1

Placebo DRUG

Placebo 1 po BID for 2 weeks

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

You may not qualify if:

• Any diabetic subject with a HgbA1C level of \<7% or \>11%
• Evidence of atherosclerosis
• symptoms of angina
• symptoms of claudication
• symptoms of cerebrovascular ischemia
• findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements
• hypertension defined as a systolic blood pressure \> = 150 mmHg and a diastolic blood pressure \>= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)
• hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels \>130mg/dL.
• renal insufficiency (serum creatinine \>1.5 mg/dL for men; \>1.2 mg/dL for women)
• hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal
• chronic pulmonary disease
• congestive heart failure
• pregnancy (or subjects planning to become pregnant);
• history of cigarette smoking within the last five years;
• history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hosptial

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005.

  PMID: 32483557 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

ebselen

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark A Creager, MD

  Brigham and Women's Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 1999
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 30, 2008

Record last verified: 2008-09

Locations

US (1)