L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release (LNMMA)
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|ClinicalTrials.gov Identifier: NCT03534661|
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemias||Drug: Teduglutide + Normal Saline Drug: Teduglutide + L-NMMA Drug: Placebo + L-NMMA||Phase 2 Phase 3|
This is a single-blind, cross over, Phase 3b clinical study. The protocol aims to study 15 healthy, lean, non-diabetic males and females for three studies each, in random order, approximately four weeks apart, as follows.
Study A (L-NMMA + Teduglutide study): Volunteers will receive high-fat nutritional drink and seven hours later a subcutaneous injection of Teduglutide (0.05mg/kg of body weight, which is the FDA-approved route and daily dose for the treatment of short bowel syndrome).Thirty minutes prior to Teduglutide, the subject will receive an intravenous infusion of L-NMMA up to a maximum amount of 10 mg/kg, to inhibit nitric oxide synthesis. Lipid and lipoprotein levels will be measured at regular intervals for 3 hours following the injection of Teduglutide. Mesenteric blood flow will be measured at regular intervals by ultrasonography on some volunteers.
Study B (Teduglutide + normal saline): The design is identical to study A, except that, instead of L-NMMA, normal saline of the same volume will be infused.
Study C (Placebo + L-NMMA): The design is identical to study A, except that, instead of Teduglutide, a placebo will be injected subcutaneously.
Mesenteric Blood Flow measurement: Mesenteric blood flow will be measured at the bedside for some of the volunteers by ultrasonography in each study (A, B, C) before, during and after the administration of L-NMMA and Teduglutide. The first evaluation will begin 15 min before the start of the L-NMMA infusion and periodically afterwards.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Each participant receives 3 randomized treatments.|
|Masking Description:||Single-blinded for participants|
|Primary Purpose:||Basic Science|
|Official Title:||Role of a Nitric Oxide Synthase Inhibitor on GLP-2 Mediated Intestinal Lipoprotein Release|
|Actual Study Start Date :||September 27, 2017|
|Actual Primary Completion Date :||March 20, 2019|
|Actual Study Completion Date :||March 20, 2019|
Placebo Comparator: Teduglutide + Normal Saline
Teguglutide + (L-NMMA control)
Drug: Teduglutide + Normal Saline
Teduglutide 0.05 mg/kg subcutaneous injection; Normal Saline intravenous infusion
Other Name: L-NMMA control
Active Comparator: Teduglutide + L-NMMA
Tedulgutide + L-NMMA
Drug: Teduglutide + L-NMMA
Teduglutide 0.05 mg/kg subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion
Other Name: active treatments
Placebo Comparator: Placebo + L-NMMA
(Teduglutide control) + L-NMMA
Drug: Placebo + L-NMMA
Placebo subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion
Other Name: Teduglutide control
- Plasma Lipid Levels [ Time Frame: 10.5 hours ]Lipid levels in plasma and lipoprotein fractions are measured following treatments
- Blood Flow [ Time Frame: 3 hours ]Mesenteric blood flow rates are measured with ultrasound following treatments
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): NCT03534661
|Tornto General Hospital, UHN|
|Toronto, Ontario, Canada, M5G 1L7|