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Effect of Arginine on Microcirculation in Patients With Diabetes

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. Identifier: NCT00902616
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : November 27, 2013
Information provided by:
Tameside Hospital NHS Foundation Trust

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: L-arginine Dietary Supplement: Placebo Lactose powder Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : June 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older 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

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 identifier (NCT number): NCT00902616

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United Kingdom
Tameside General Hospital
Ashton-under-Lyne, Cheshire, United Kingdom, OL6 9RW
Sponsors and Collaborators
Tameside Hospital NHS Foundation Trust
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Principal Investigator: Edward Jude, MD, MRCP Tameside General Hospital
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Responsible Party: Mr Philip Dylak, Tameside General Hospital Identifier: NCT00902616    
Other Study ID Numbers: Arginine01
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: May 2009
Keywords provided by Tameside Hospital NHS Foundation Trust:
Type 2 diabetes
Peripheral neuropathy
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases