NCT00767741

Brief Summary

The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 4, 2013

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

October 4, 2008

Last Update Submit

April 3, 2013

Conditions

Diabetes

Keywords

diabetespost prandial glucose levelinsulinpharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Insulin blood level with and with out the intervention

    at the end of every daily study

Study Arms (1)

with treatment

EXPERIMENTAL
Device: with heat and massage

Interventions

with heat and massageDEVICE

For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.

with treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant age between 18- 65 years old
  • Type I or Type II diabetes
  • HbA1c 6-12%
  • Does not suffer from sever hypertension, kidney, liver or heart disease
  • Does not suffer from active Ischemic heart disease
  • Is willing to sign the consent form

You may not qualify if:

  • Participants age \< 18 or \> 65
  • Pregnancy
  • Breast feeding women
  • Un-controlled diabetes, HbA1c values \> 12% range
  • Suffers from active Ischemic heart disease
  • Alcohol addiction
  • Is not prepared to signed the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical center

Jerusalem, Other, 97279, Israel

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Massage

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2008

First Posted

October 7, 2008

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 4, 2013

Record last verified: 2011-06

Locations

IL(1)