Impact of a Program of Non-pharmacological Intervention i... | NCT02456064

Studies
Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus

NCT02456064

Sponsor

Equipo Multidisciplinar Sanitario CS Foietes

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

Lifestyle counseling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 24, 2015

First Submission Date that Met QC Criteria

May 27, 2015

First Posted Date

May 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2017

Last Update Posted Date

Mar 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.

Detailed Description

This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .

In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.

We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle counseling	Experimental	In this group we will make an intensive program based on: workshops, educational talks, group medical practices and "expert patient" among others conduct auditions.	Behavioral: Lifestyle counseling
Normal group	No Intervention	In this group will be controlled as usual in the consultations.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle counseling	Behavioral	Group medical visits Telephone medical consultations Expert patient Training workshops	Lifestyle counseling

Measure	Description	Time Frame
HbA1c		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus with poor control of their disease.
No changes have been made in pharmacological previous 3 months.

Exclusion Criteria:

Changes in their drug treatment in the past 3 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ivan S Silvera		Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided