Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2015 |
| End Date: | August 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Fort Collins, Colorado 80523
Principal Investigator: Benjamin F Miller, PhD
Phone: 970-491-3291
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