NCT02065544

Brief Summary

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

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

Timeline
Completed

Started Feb 2012

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

Study Start

First participant enrolled

February 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

February 11, 2014

Last Update Submit

February 18, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusbehavioral weight lossexercise traininghemoglobin A1c

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.

    6-months

Secondary Outcomes (3)

  • lipid profile

    6 months

  • HS-C Reactive Protein

    6 months

  • Aerobic Fitness

    6 months

Study Arms (1)

behavioral weight loss and exercise

EXPERIMENTAL

weight loss and exercise lifestyle intervention over a 6 month period

Behavioral: behavioral weight loss and exercise

Interventions

behavioral weight loss and exerciseBEHAVIORAL

Weight loss and exercise counseling

behavioral weight loss and exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • new diagnosis of type 2 diabetes since 12 months
  • BMI\>27
  • HBA1c \> 6.5, , 8.0

You may not qualify if:

  • HBA1c \>8.0
  • BMI\< 27

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip A Ades, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 19, 2014

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02