Non-Response to Exercise (NRE2)

University Hospital Tuebingen

Status: Completed

Conditions: Non-Responder

Treatments: Behavioral: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03151590

446/2016BO2

Details and patient eligibility

About

The purpose of this prospective intervention study is to find biomarkers and underlying pathomechanisms for non-response of improvement in glucose metabolism to exercise.

An additional goal is to identify non-responders at an early stage, where prevention strategies (pharmacologically or by specific training) will be successful.

Full description

At baseline and end of study, an intensive metabolic phenotyping including cerebral insulin sensitivity as well as tissue biopsies are performed in overweight untrained healthy participants at high risk for type 2 diabetes. During the study, an individual exercise training at 80% VO2max is performed for 9 weeks. Before and after the training intervention, acute tissue biopsies after a standardized bout of exercise are obtained.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least one of the following risk factors for type 2 diabetes:

  • overweight (BMI>27 kg/m2)
  • impaired fasting glucose and/ or glucose tolerance
  • former gestational diabetes
  • family history for type 2 diabetes (first-degree relative)

• sedentary participant (< 2 exercise bouts/week)

Exclusion criteria

• any kind of metal in or on the body
• thermosensory or heightened sensitivity to heating
• heightened sensitivity to loud noise or diseases of the ear
• claustrophobia
• Diabetes mellitus
• current pregnancy or breastfeeding
• cardiovascular diseases
• surgery, < 3 months ago
• participation in other clinical trials
• acute illness/infection, < 4 weeks ago
• severe mental illness
• hemoglobin, women < 11g/dl, men < 13g/dl
• potentially incompliant subjects and/or inability to absolve the exercise training
• glucose influencing drugs
• continuous analgetic drugs
• use of anticoagulants

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)