NCT00902616

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Jun 2003

Typical duration for phase_4 type-2-diabetes

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

June 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
Last Updated

November 27, 2013

Status Verified

May 1, 2009

Enrollment Period

3 years

First QC Date

May 12, 2009

Last Update Submit

November 26, 2013

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesPeripheral neuropathyMicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Improvement in microcirculation

    3 months

Secondary Outcomes (1)

  • Effect of L-arginine on clinical parameters of neuropathy

    3 months

Study Arms (2)

1. L-arginine

ACTIVE COMPARATOR

3 gm TDS for 3 months

Dietary Supplement: L-arginine

2. Placebo - Lactose powder

PLACEBO COMPARATOR

3 gm TDS for 3 months

Dietary Supplement: Placebo Lactose powder

Interventions

L-arginineDIETARY_SUPPLEMENT

3gm TDS for three months

1. L-arginine
Placebo Lactose powderDIETARY_SUPPLEMENT

3gm TDS for 3 months

2. Placebo - Lactose powder

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tameside General Hospital

Ashton-under-Lyne, Cheshire, OL6 9RW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Peripheral Nervous System Diseases

Interventions

Arginine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Edward Jude, MD, MRCP

    Tameside General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 15, 2009

Study Start

June 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 27, 2013

Record last verified: 2009-05

Locations

GB(1)