Oral Nitrite Trial for Hypertension and Metabolic Syndrome

NCT02517697 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: PRO15050540
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate effects of inorganic sodium nitrite on the cardiometabolic and hormonal disturbances observed in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction.

Conditions

Metabolic Syndrome; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity (i.e. insulin stimulated glucose disposal)

  obtained by hyperinsulinemic euglycemic clamp

  baseline and 12 weeks

Secondary Outcomes (4)

• Change in systolic blood pressure

  baseline and 12 weeks

• Change in mean arterial pressure

  baseline and then biweekly throughout the 12 week treatment

• Change in diastolic blood pressure

  baseline and 12 weeks

• Change in methemoglobin level

  baseline and then biweekly throughout the 12 week treatment

Study Arms (2)

Active drug

EXPERIMENTAL

14 Nitrogen (N) Sodium Nitrite 40mg three times daily (TID)

Drug: 14 Nitrogen (N) Sodium Nitrite

Placebo

PLACEBO COMPARATOR

placebo capsules three time daily (TID)

Drug: Placebo

Interventions

14 Nitrogen (N) Sodium Nitrite DRUG

oral formulation of sodium nitrite 40 mg three times daily for 12 weeks

Also known as: sodium nitrite

Active drug

Placebo DRUG

oral formulation of matching placebo three times daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Body mass index (BMI) ≥ 30 kg/m2
• Hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure ≥85 mm Hg
• Waist circumference: \>102 cm in men, \>88 cm in women

You may not qualify if:

• Positive urine pregnancy test or breastfeeding
• Concurrent use of medications affecting glucose metabolism (oral hypoglycemics, insulin, atypical antipsychotics)
• Recent addition or change in dosing of hormonal contraceptive medications (Oral Contraceptive Pill (OCP), Intra Uterine Device (IUD), DepoProvera shot)
• Current use of ≥3 anti-hypertensive agents regardless of blood pressure control or normotensive on a single or double agent
• Current use of phosphodiesterase-5 (PD) inhibitors or organic nitrates. We will not exclude for dietary sources of nitrate/nitrite.
• Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
• Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
• Thyroid Stimulating Hormone (TSH) \>8 milli-International unit/mL
• Smoker
• Anemia (central lab hemoglobin \< 11g/dL)
• Active periodontal disease

Sponsors & Collaborators

• Gladwin, Mark, MD: lead

Study Sites (1)

Montefiore Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kara S Hughan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Mark Gladwin, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: October 1, 2020
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)