NCT01402388

Brief Summary

The study seeks to establish if weight loss achieved through a program of intensive lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients with newly diagnosed type 2 diabetes mellitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable type-2-diabetes

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

October 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

July 25, 2011

Last Update Submit

July 25, 2011

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Lifestyle impact on GLP-1, HbA1c and fasting glycaemia.

    8 months following commencement of study.

Study Arms (1)

Lifestyle intervention group.

EXPERIMENTAL
Behavioral: Group lifestyle programme

Interventions

Group lifestyle programmeBEHAVIORAL
Lifestyle intervention group.

Eligibility Criteria

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

You may qualify if:

  • New onset type 2 Diabetes
  • Body mass index 25 and above
  • Able to give informed consent

You may not qualify if:

  • Hypoglycaemic and antiobesity agents, or any other prescription medication that may interfere with study results

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

October 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 26, 2011

Record last verified: 2011-07