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

NCT ID: NCT02552355

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-08-31

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Metformin/Carbohydrate

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: 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.

Carbohydrate Beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo/Carbohydrate

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Carbohydrate Beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Metformin/Protein

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: 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.

Protein Beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo/Protein

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

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

Protein Beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Metformin

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Carbohydrate Beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Protein Beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Glumetza; Fortamet; Glucophage; Riomet

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Miller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://tracd.colostate.edu/

Lab website

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351883/

Final Publication

Other Identifiers

15-8573H

Identifier Type: -

Identifier Source: org_study_id