NCT02456064

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

May 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

May 24, 2015

Last Update Submit

March 25, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    6 months

Study Arms (2)

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

Lifestyle counselingBEHAVIORAL

* Group medical visits * Telephone medical consultations * Expert patient * Training workshops

Lifestyle counseling

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Changes in their drug treatment in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ivan S Silvera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share