Study Stopped
PI left the VA, per Central Office
Regulation of B-Cell Function & Glucose Tolerance in Older People
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise training improves the body's production of insulin in older people at risk to develop diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
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
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 5, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 11, 2011
August 1, 2011
3.8 years
November 5, 2007
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise effect on beta-cell function at 3 months
3 months
Secondary Outcomes (1)
Exercise effects glucose tolerance, intraabdominal fat, lipids, glycerol, GLP-1, adiponectin, and leptin.
3 months
Study Arms (3)
1
ACTIVE COMPARATORExercise
2
ACTIVE COMPARATORExercise
3
NO INTERVENTIONControl
Interventions
Eligibility Criteria
You may qualify if:
- Sedentary (defined as activity level of no more than occasional short bouts of walking per week), community-dwelling older veterans and non-veterans age 60-80 years. Special recruitment efforts will focus on enrollment of veterans.
- Fasting glucose \<126 mg/dl and 2-hr glucose 140-199 mg/dl (IGT) during OGTT.
- BMI 26-36 kg/m2.
You may not qualify if:
- Current use of oral anti-diabetic agents, insulin, systemic steroids, beta-blockers, thiazides.
- Abnormal screening exercise stress test: exercise-induced sustained arrhythmia, symptomatic myocardial ischemia, ischemic EKG changes (\>2mm ST-T depression in non Q-wave lead) during screening maximum treadmill test.
- Clinically significant cardiac disease defined as congestive heart failure (CHF) requiring pharmacologic therapy or New York Heart Association (NYHA) Class 3 or 4 cardiac status, atrial fibrillation, symptomatic obstructive valvular disease, high-grade AV block, unstable angina, or myocardial infarction within the last 12 months.
- Participation in a physical therapy, exercise or diet program.
- Significant orthopedic or musculoskeletal conditions.
- Clinically significant renal disease and/or serum creatinine \> 2.0 mg/dl.
- Hemoglobin \<10 g/l.
- Clinically significant liver disease and/or ALT \> 2.5 fold the upper limit of normal.
- Clinically significant medical history or physical findings (e.g. chronic lung disease, cancer) detected at the screening assessment.
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- American Diabetes Associationcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
November 5, 2007
First Posted
November 6, 2007
Study Start
November 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 11, 2011
Record last verified: 2011-08