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NCT01122407
Obesity, Hypertension in African American Women, Neuro-metabolic Mechanism
Phase 1 trial testing L-NMMA in Obesity in 34 participants. Completed in 1 November 2016.
1 November 2016
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Enrollment | 34 |
| Start date | 1 January 2010 |
| Primary completion | 1 November 2016 |
| Estimated completion | 1 November 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- L-NMMA — full drug profile →
- Trimethaphan — full drug profile →
Conditions studied
- Obesity — all drugs for Obesity →
- Hypertension — all drugs for Hypertension →
Sponsor
Vanderbilt University Medical Center
Who can join
Adults 30 to 50, female only, with Obesity or Hypertension. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
change in systolic blood pressure in response to trimethaphan, as a measurement of the tonic sympathetic contribution to blood pressure.
Time frame: 30 minutes after initiation of Trimethaphan infusion
Will infuse trimethaphan for until complete autonomic blockade is achieved.
Sponsor's own description
The overall goal of this proposal is to determine the autonomic and nitric oxide contribution in the pathogenesis of hypertension and insulin resistance in obese African American women. For this purpose we will use two non-FDA approved drugs: Trimethaphan IND# 63826 Approval date 12/20/2001 L-NMMA IND# 41735 Approval date 09/1993
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hypertension in Obese Black Women is Not Caused by Increased Sympathetic Vascular Tone.
Marinos A, Gamboa A, Celedonio JE, Preheim BA, et al · · 2017 · cited 14× · PMID 29151035 · DOI 10.1161/jaha.117.006971 -
Complete autonomic blockade reveals nitric oxide contribution to blood pressure regulation in obese Black women.
Rahman S, Gamboa A, Saleem M, Kulapatana S, et al · · 2024 · PMID 39090323 · DOI 10.1007/s10286-024-01050-3
Verify or expand the search:
- PubMed search for NCT01122407
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Vanderbilt University Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01122407 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 16 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01122407.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing