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Effect of Arginine on Microcirculation in Patients With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902616
First Posted: May 15, 2009
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tameside Hospital NHS Foundation Trust
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: L-Arginine and Endothelial Dysfunction in Type 2 Diabetic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement in microcirculation [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Effect of L-arginine on clinical parameters of neuropathy [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: Mr Philip Dylak, Tameside General Hospital
ClinicalTrials.gov Identifier: NCT00902616     History of Changes
Other Study ID Numbers: Arginine01
First Submitted: May 12, 2009
First Posted: May 15, 2009
Last Update Posted: November 27, 2013
Last Verified: May 2009

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

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