Nutraceutical Citrulline in Pregnancy

Sponsor

University of Pittsburgh (Other)

Overall Status

Terminated

CT.gov ID

NCT02772887

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of placental growth factor (PlGF).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: L-Citrulline Other: Placebo	N/A

Detailed Description

The pregnancy-specific syndrome preeclampsia is a leading cause of maternal and fetal morbidity and mortality. The underlying cause of preeclampsia is unknown, however several pre-existing maternal conditions are associated with an increased risk of preeclampsia including: diabetes, hypertension, renal dysfunction, obesity and history of preeclampsia. Specifically, the risk of preeclampsia is five times greater in women with diabetes.

Several lines of evidence indicate that endothelial dysfunction is a central feature of the pathophysiology of preeclampsia. Asymmetric dimethylarginine (ADMA) is a methylated metabolite of the amino acid L-arginine and an endogenous inhibitor of nitric oxide synthase (NOS). High concentrations of ADMA contribute to endothelial dysfunction and ADMA inhibits angiogenesis and arteriogenesis, activities important in pregnancy and deficient in preeclampsia. ADMA concentrations are higher early in pregnancy among women who later develop preeclampsia. This protocol describes a randomized placebo-controlled trial of L-citrulline in 40 pregnant women with type 2 diabetes from approximately sixteen to nineteen weeks gestation, to determine whether L-citrulline supplementation increases the plasma L-arginine/ADMA ratio, lowers maternal blood pressure and increases a circulating marker of placental function (placental growth factor PLGF).

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

Phase 1 Trial Citrulline and Type 2 Diabetes in Pregnancy

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citrulline Oral L-citrulline, 3 grams once per day for 3 weeks.	Dietary Supplement: L-Citrulline amino acid supplement
Placebo Comparator: Placebo Placebo, 3 grams once per day for 3 weeks.	Other: Placebo placebo

Arm

Intervention/Treatment

Experimental: Citrulline

Oral L-citrulline, 3 grams once per day for 3 weeks.

Dietary Supplement: L-Citrulline

amino acid supplement

Placebo Comparator: Placebo

Placebo, 3 grams once per day for 3 weeks.

Other: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Blood pressure [approximately 20 weeks]
research measure

Secondary Outcome Measures

Placental growth factor (PlGF) [approximately 20 weeks]
quantified by ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Singleton pregnancy
Type 2 diabetes with hemoglobin A1c <8
Gestational age at randomization between 14 and 16 weeks based on clinical information
Maternal age between 14 and 40 years