NCT00010751

Brief Summary

The object of this study is to determine if Reiki will improve glycemic control and cardiac autonomic function diabetic patients with painful neuropathy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2

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

September 1, 1998

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

February 2, 2001

Last Update Submit

August 17, 2006

Conditions

Coronary DiseaseDiabetes Mellitus, Non-Insulin-Dependent

Interventions

ReikiPROCEDURE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* NIDDM as defined by the World Health Organization * Diagnosed with DPN +/- DAN for a duration of no less than six months * Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation * Stability of diabetes control by documentation of \<1% fluctuation of HbA1c levels over the last twelve months and 3 or less mild hypoglycemic reactions per week. All subjects must be prepared to monitor blood glucose values three to four times daily * HbA1c should be \<10% * Ability to give informed consent and willingness to sign the Institutional Review Board approved consent form * Willingness to cooperate with medical therapy and follow up for the 12 months of the study duration * Have the ability to understand English

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Taubman Center

Ann Arbor, Michigan, 48109-0344, United States

Location

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus, Type 2

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Martin Stevens, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Study Start

September 1, 1998

Study Completion

June 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)