Clinical trial NCT02552355: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Physical Activity
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 56
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either Metformin-Protein, Metformin-Carbohydrate, Placebo-Protein, and Placebo-Carbohydrate.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Mitochondrial Function
timeFrame: Baseline and 12 weeks
measure: Protein Synthesis
timeFrame: 12 weeks
measure: Body Composition
timeFrame: Baseline and 12 weeks
measure: Insulin Sensitivity
timeFrame: Baseline and 12 weeks
measure: Peak Aerobic Capacity
timeFrame: Baseline and 12 weeks
measure: DNA Synthesis
timeFrame: Baseline and 12 weeks
measure: Glucose Tolerance
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Intracellular Signaling Proteins
timeFrame: Baseline and 12 weeks
measure: Glucose Profiles From Real-Time Continuous Glucose Monitoring
timeFrame: Baseline, Weeks 6-8, 12 weeks
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University, Dept. of Health and Exercise Science
state: Colorado
Study officials:
References: