NCT00917449

Brief Summary

Aim The principal objective of this project is:

  1. 1.To define if a long term treatment with L-arginine is able to ameliorate insulin sensitivity and endothelial dysfunction in this population.
  2. 2.To find new risk profiles and candidate genes able to define the sub-group of patients at higher risk to develop type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

3.5 years

First QC Date

June 9, 2009

Last Update Submit

June 9, 2009

Conditions

Metabolic SyndromeImpaired Glucose ToleranceInsulin ResistanceEndothelial Dysfunction

Keywords

Metabolic SyndromeImpaired glucose toleranceType 2 diabetes mellitusEndothelial dysfunctionL-arginineInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or delaying clinical onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (IGT) and Metabolic Syndrome.

    18 months

Secondary Outcomes (1)

  • Define if the treatment with L-arginine can ameliorate insulin sensitivity and endothelial dysfunction and find new risk profiles and candidate genes able to characterize the sub-group of patients at higher risk to develop type 2 diabetes mellitus.

    18 months

Study Arms (2)

L-arginine

ACTIVE COMPARATOR

L-arginine (3.2 gr bid) plus lifestyle counselling vs placebo plus lifestyle counselling

Drug: L-arginine

placebo

PLACEBO COMPARATOR

placebo plus lifestyle counselling for 18 months

Drug: Placebo

Interventions

L-arginineDRUG

Oral L-arginine (3.2 gr bid)for 18 months

Also known as: bioarginine
L-arginine
PlaceboDRUG

Oral Placebo BID for 18 months

placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent must be obtained before any procedure of the study is done.
  • Male or Female aged more than 35 years.
  • Diagnosis of IGT after a standard Glucose Tolerance Test (OGTT, 75 g)
  • Moreover, in order to be considered affected by Metabolic Syndrome, they must have two or more of the following criteria:
  • Abdominal obesity (waist\>120 cm for man, \>88 cm for women)
  • Hypertriglyceridemia (\>150 mg/dl)
  • Low HDL cholesterol (\<40mg/dl in man, \<50 mg/dl in woman)
  • Hypertension (\>130 / \>85 mmHg)

You may not qualify if:

  • Presence of type 1 or type 2 diabetes mellitus
  • Fasting glucose levels \>126 mg/dl
  • Sitting Systolic Arterial Pressure \>140mmHg, and Sitting Diastolic Arterial Pressure \>90mmHg
  • Pregnancy
  • Known renal insufficiency or creatinine levels more than 1.8 mg/dl,
  • Presence of chronic hepatopathy or levels of ALT and AST more than two standard deviations from normality levels
  • Presence of malignancy
  • Abuse of alcohol or abuse substances
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute San Raffaele

Milan, Milan, 20132, Italy

Location

Related Publications (2)

  • Monti LD, Galluccio E, Villa V, Fontana B, Spadoni S, Piatti PM. Decreased diabetes risk over 9 year after 18-month oral L-arginine treatment in middle-aged subjects with impaired glucose tolerance and metabolic syndrome (extension evaluation of L-arginine study). Eur J Nutr. 2018 Dec;57(8):2805-2817. doi: 10.1007/s00394-017-1548-2. Epub 2017 Oct 20.

    PMID: 29052766DERIVED

  • Monti LD, Galluccio E, Fontana B, Spadoni S, Comola M, Marrocco Trischitta MM, Chiesa R, Comi G, Bosi E, Piatti P. Pharmacogenetic influence of eNOS gene variant on endothelial and glucose metabolism responses to L-arginine supplementation: Post hoc analysis of the L-arginine trial. Metabolism. 2015 Nov;64(11):1582-91. doi: 10.1016/j.metabol.2015.08.015. Epub 2015 Aug 28.

    PMID: 26385052DERIVED

MeSH Terms

Conditions

Metabolic SyndromeGlucose IntoleranceInsulin ResistanceDiabetes Mellitus, Type 2

Interventions

Arginine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemiaDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • PierMarco Piatti, MD

    Scientific Institute San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

December 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations

IT(1)