Phase 2
N=56
Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin
Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT02552355 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Mitochondrial Function — 7.1; 43.2; 15.6; 13.8 percent change in pmol/s/mg tissue
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug); Placebo (Drug); Carbohydrate Beverage (Dietary_supplement); Protein Beverage (Dietary_supplement)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mitochondrial Function |
7.1; 43.2; 15.6; 13.8; 3.4; 42.3 | — |
| PRIMARY Protein Synthesis |
1.24; 1.15; 1.1; 1.14; 1.15; 1.00 | — |
| PRIMARY Body Composition |
48; 48; 50; 46; 47; 48 | — |
| PRIMARY Insulin Sensitivity |
86; 57; 39; 56; 91; 51 | — |
| PRIMARY Peak Aerobic Capacity |
3; 4.7; 4.9; 8.5 | — |
| PRIMARY DNA Synthesis |
— | — |
| PRIMARY Glucose Tolerance |
131; 116; 108; 102; 133; 115 | — |
| SECONDARY Intracellular Signaling Proteins |
154.3; 677.5; 321.1; 106.9; 151.8; 563.2 | — |
| SECONDARY Glucose Profiles From Real-Time Continuous Glucose Monitoring |
116; 116.7; 113.3; 107.1; 105.3; 104.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02552355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.