The impact of metformin and physical exercise interaction on HbA1c, lipid profile and functional capacity (Metformin and physical exercise interaction)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Treatments interaction

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METFORMIN
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  To examine the impact of the interaction between metformin use and physical exercise on HbA1c level, lipid profile and functional capacity among diabetic adults. Also to examine the effect of different doses of exercise on the primary outcomes among diabetic metformin users.
• Outcomes:
  1) the HbA1c level 2) the lipid profile measured at discharge 3) the distance walked over a total of six minutes, using the standard 6-minute walk test (6MWT).
• Data analysis plan:
  Directed acyclic graphs (DAG) will be used to identify potential confounders and specify variables to be included in the models. DAGs will be used to estimate both the total and direct effects of exercise doses in separate models.