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Effect of Arginine on Microcirculation in Patients With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Tameside Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00902616
First received: May 12, 2009
Last updated: May 22, 2009
Last verified: May 2009
History of Changes
  Purpose

Patients with diabetes have dysfunction of the lining of the arteries which lead to impaired circulation in the small blood vessels. This is thought to be secondary to reduced chemicals in the blood viz: nitric oxide. This chemical is derived from an amino acid (protein) L-arginine. Therefore, the researchers investigated whether giving patients L-arginine (versus dummy powder) would improve the blood flow in the small blood vessels in the lower limbs of patients with damage to their nerves (neuropathy).


Condition Intervention Phase
Type 2 Diabetes
 Dietary Supplement: L-arginine
Dietary Supplement: Placebo Lactose powder
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: L-Arginine and Endothelial Dysfunction in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tameside Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Improvement in microcirculation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of L-arginine on clinical parameters of neuropathy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. L-arginine
3 gm TDS for 3 months
 Dietary Supplement: L-arginine
3gm TDS for three months
Placebo Comparator: 2. Placebo - Lactose powder
3 gm TDS for 3 months
 Dietary Supplement: Placebo Lactose powder
3gm TDS for 3 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females diabetic patients with peripheral neuropathy, aged 30-65 years

  • Type 2 diabetes (NIDDM) judged by WHO criteria:

    • onset of diabetes mellitus after the age of 30 years
    • not requiring insulin for control of diabetes or insulin treatment initiated after one year diagnosis of diabetes
    • no history of diabetic ketoacidosis
  • All patients will have detailed history and physical examination

Exclusion Criteria:

  • Patients with ischaemic heart disease
  • Previous stroke and severe peripheral vascular disease)
  • Previous amputation
  • Renal failure (defined as serum creatinine > 120 mmol/l)
  • Uncontrolled hypertension (BP > 160/90)
  • Patients on nitrates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902616

Locations
United Kingdom
Tameside General Hospital
Ashton-under-Lyne, Cheshire, United Kingdom, OL6 9RW
Sponsors and Collaborators
Tameside Hospital NHS Foundation Trust
Investigators
Principal Investigator: Edward Jude, MD, MRCP Tameside General Hospital
  More Information

No publications provided

Responsible Party: Mr Philip Dylak, Tameside General Hospital
ClinicalTrials.gov Identifier: NCT00902616     History of Changes
Other Study ID Numbers: Arginine01
Study First Received: May 12, 2009
Last Updated: May 22, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Tameside Hospital NHS Foundation Trust:
Type 2 diabetes
Peripheral neuropathy
Microcirculation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013