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Effect of Arginine on Microcirculation in Patients With Diabetes

This study has been completed.
Information provided by:
Tameside Hospital NHS Foundation Trust Identifier:
First received: May 12, 2009
Last updated: November 26, 2013
Last verified: May 2009
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


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00902616

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

Responsible Party: Mr Philip Dylak, Tameside General Hospital Identifier: NCT00902616     History of Changes
Other Study ID Numbers: Arginine01
Study First Received: May 12, 2009
Last Updated: November 26, 2013

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 18, 2017