Metabolic changes in obese patients with diabetes mellitus - impact of weight reduction

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Clinical trials

• Clinical trial regulatory scope:
  Pre-authorisation clinical trial
• Clinical trial phase:
  Human pharmacology (Phase I)

  Therapeutic exploratory (Phase II)

  Therapeutic confirmatory (Phase III)

Study drug and medical condition

• Medical condition to be studied:
  Diabetes mellitus management

Population studied

• Short description of the study population:
  Obese and non-obese patients with diabates mellitus type 1, and obese patients with diabetes mellitus type 2.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  Obesity has become a serious problem among type 1 diabetics. These patients create an interresting subgroup with combination of metabolic disorders - absolute insulin lack and increased insulin resistance. Insulin resistance has been well characterised in obese patients with diabetes mellitus type 2, the subgroup of obese diabetics type 1 needs further research in lipid metabolism.
• Data analysis plan:
  We estimated metabolic parameters of obese type 1 diabetics and compared them with subgroup of lean patients with diabetes mellitus type 1. We characterised the dynamic of metabolic parameters in obese type 1 diabetics during our weight reduction programme with acute and chronical phase of weight reduction. Measurements were done before (Phase I), after a month (Phase II) (one week of fasting in the hospital setting and three weeks on a diet containing 150g saccharides per day) and after one year (Phase III) on a diet with 225g saccharides per day. The main observed characteristics were: anthropometry, body composition, diabetes compensation, insulin resistance, markers of cholesterol metabolism, adipokines.