Expired Study
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Fort Collins, Colorado 80523


Purpose:

The investigators propose that post-exercise milk protein feeding will enhance the mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In addition, the investigators propose that this stimulatory effect of protein feeding will overcome the potential blunting effect of metformin on exercise responses. The investigators will investigate these outcomes over a 12-week exercise-training program in older adults with pre-diabetes with or without metformin treatment.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

15-8573H


NCT ID:

NCT02552355


Secondary ID:


Study Acronym:


Brief Title:

Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin


Official Title:

Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Colorado State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Study Dates

Start Date:August 2015
Completion Date:August 2017
Completion Type:Actual
Primary Completion Date:August 2017
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 16, 2019
First Received Date:September 1, 2015
First Results Date:November 29, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mitochondrial Function
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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 ade
Outcome Type:Primary Outcome
Measure:Protein Synthesis
Time Frame:12 weeks
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Body Composition
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Insulin Sensitivity
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Peak Aerobic Capacity
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:DNA Synthesis
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description:Incorporation of Deuterium Oxide into DNA will be measured before and after the 12 week interventions.
Outcome Type:Primary Outcome
Measure:Glucose Tolerance
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Intracellular Signaling Proteins
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Glucose Profiles From Real-Time Continuous Glucose Monitoring
Time Frame:Baseline, Weeks 6-8, 12 weeks
Safety Issues:False
Description: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) .

Study Interventions

Intervention Type:Drug
Name:Metformin
Description: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.
Arm Name:Metformin/Carbohydrate
Other Name:Glumetza
Intervention Type:Drug
Name:Placebo
Description:Daily administration of matching placebo during a 12 week exercise training program.
Arm Name:Placebo/Carbohydrate
Intervention Type:Dietary Supplement
Name:Carbohydrate Beverage
Description:Supervised aerobic exercise 3 days per week followed by a carbohydrate drink
Arm Name:Metformin/Carbohydrate
Intervention Type:Dietary Supplement
Name:Protein Beverage
Description:Supervised aerobic exercise 3 days per week followed by a protein drink
Arm Name:Metformin/Protein

Study Arms

Study Arm Type:Experimental
Arm Name:Metformin/Carbohydrate
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:Placebo/Carbohydrate
Description: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.
Study Arm Type:Active Comparator
Arm Name:Metformin/Protein
Description: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
Study Arm Type:Active Comparator
Arm Name:Placebo/Protein
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Colorado State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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