- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552355
Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, placebo controlled, double blind study. 60 men and women over the age of 55 with indications of pre-diabetes will be recruited for participation and randomly assigned to one of four 12 week exercise training programs: 1)Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of Metformin. 2) Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of Metformin. 3) Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of matching placebo. 4) Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of placebo.
Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program. The titration dosing scheme and taking metformin/placebo with meals will help reduce the most common side effects (i.e.,gastrointestinal discomfort). If participants experience gastrointestinal discomfort, the dose will be lowered to 1500 mg/day.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Colorado
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Fort Collins, Colorado, United States, 80523-1582
- Colorado State University, Dept. of Health and Exercise Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 55 years or older
- Individuals with Prediabetes defined as impaired fasting glucose (100 to 126 mg/dl), HbA1c (5.7-6.4%), and/or impaired glucose tolerance defined as 2 hour postprandial blood glucose of 140 to 200 mg/dl.
Exclusion Criteria:
- Medications contraindicated with Metformin (Dofetilide, Lamotrigine, Pegvisomant, Somatropin, Trimethoprim, Trospium, Gatifloxacin, Cephalexin, Cimetidine, Dalfampridine)
- Recent (less than 6 weeks) or planned imaging that requires IV contrast,
- Renal dysfunction creatinine ≥ 1.3 mg/dL in men or ≥ 1.2 mg/dL in women
- Alanine Aminotransferase (ALT) levels exceed 52 IU/L
- Heart, Kidney or Liver Disease
- Type I or Type II Diabetes
- Anti-coagulant therapy (warfarin/heparin)
- Lung/respiratory dysfunction
- Medications affecting primary outcomes
- Lactose Intolerant
- Tobacco Use
- Heavy Alcohol Use
- Cancer
- Lidocaine Allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin/Carbohydrate
Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training.
The dose of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4. Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of Metformin.
|
Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program.
Other Names:
Supervised aerobic exercise 3 days per week followed by a carbohydrate drink
|
Placebo Comparator: Placebo/Carbohydrate
Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training.
The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4. Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of matching placebo.
|
Supervised aerobic exercise 3 days per week followed by a carbohydrate drink
Daily administration of matching placebo during a 12 week exercise training program.
|
Active Comparator: Metformin/Protein
Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training.
The dose of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week.
Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of Metformin
|
Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program.
Other Names:
Supervised aerobic exercise 3 days per week followed by a protein drink
|
Active Comparator: Placebo/Protein
Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training.
The dose of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week.
Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of placebo.
|
Daily administration of matching placebo during a 12 week exercise training program.
Supervised aerobic exercise 3 days per week followed by a protein drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mitochondrial Function
Time Frame: Baseline and 12 weeks
|
Oxygen consumption was assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.
This outcome was assessed via 2 different protocols; Protocol 1 was a substrate-uncoupler-inhibitor titration (SUIT) and Protocol 2 was an adenosine diphosphate (ADP) titration.
These data are reported as the percent change from baseline compared to 12 weeks.
|
Baseline and 12 weeks
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Protein Synthesis
Time Frame: 12 weeks
|
Incorporation of deuterium into proteins to calculate cumulative synthesis rates.
Protein synthesis was measured in sub cellular fractions of skeletal muscle including mixed, cytoplasmic and mitochondrial enriched fractions.
These data are reported as the mean at 12 weeks.
|
12 weeks
|
Body Composition
Time Frame: Baseline and 12 weeks
|
Dual energy x-ray absorptiometry was used to assess fat-free and fat mass.
These data are reported as the mean at baseline (pre) and mean at 12 weeks (post).
|
Baseline and 12 weeks
|
Insulin Sensitivity
Time Frame: Baseline and 12 weeks
|
Oral glucose tolerance test was used to measure whole-body insulin sensitivity.
These data are reported as the mean at baseline (pre) and the mean at 12 weeks (post).
|
Baseline and 12 weeks
|
Peak Aerobic Capacity
Time Frame: Baseline and 12 weeks
|
Indirect calorimetry was used to measure peak oxygen consumption during a maximal, graded exercise test.
These data are reported as the percent change from baseline compared to 12 weeks.
|
Baseline and 12 weeks
|
DNA Synthesis
Time Frame: Baseline and 12 weeks
|
Incorporation of Deuterium Oxide into DNA will be measured before and after the 12 week interventions.
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Baseline and 12 weeks
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Glucose Tolerance
Time Frame: Baseline and 12 weeks
|
Oral glucose tolerance test was used to measure glucose tolerance.
These data are reported as the mean at baseline (pre) and the mean at 12 weeks (post).
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intracellular Signaling Proteins
Time Frame: Baseline and 12 weeks
|
Protein content of intracellular signaling proteins that are implicated in mitochondrial biogenesis, mitochondrial function and insulin sensitivity were measured by Western blotting.
Densitometry results are reported as a ratio of protein divided by total amount of protein expressed.
All proteins of interest are expressed as phosphorylated relative to total.
These data are reported as the percent change from baseline compared to 12 weeks.
|
Baseline and 12 weeks
|
Glucose Profiles From Real-Time Continuous Glucose Monitoring
Time Frame: Baseline, Weeks 6-8, 12 weeks
|
Data derived from Continuous Glucose Monitoring was used to calculate mean glucose and mean average glucose excursions (MAGE).
These data are reported as the percent change at baseline (pre), 6-8 weeks (Mid), and 12 weeks (post) .
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Baseline, Weeks 6-8, 12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-8573H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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