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Completed

NCT Number: NCT02552355

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

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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: Glumetza, Fortamet, Glucophage, Riomet

Placebo

Drug

Daily administration of matching placebo during a 12 week exercise training program.

carbohydrate beverage

Dietary Supplement

Supervised aerobic exercise 3 days per week followed by a carbohydrate drink

Protein Beverage

Dietary Supplement

Supervised aerobic exercise 3 days per week followed by a protein drink

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. DNA Synthesis

    Time frame: Baseline and 12 weeks

    Incorporation of Deuterium Oxide into DNA will be measured before and after the 12 week interventions.

  7. 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).

Secondary outcomes

  1. 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.

  2. 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) .

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2015
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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