Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover, Bone remodeling
Brief summary
Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.
Sponsors
Hvidovre University Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Eligibility
Sex/Gender
MALE
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Age 25 to 70 years old. * Type 2 diabetes. * In Metformin or sulfonylureas
Exclusion criteria
* Treatment with other antidiabetics * Osteopososis or gastrointestinal disease * Smoking * Long term steroid treatment * Weight change more than 3 kg within the last 3 months. * Overweight or intestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTX | -10 minutes to 240 minutes | Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum. |
| P1NP | -10 minutes to 240 minutes | Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | -10 minutes to 240 minutes | Measured in serum |
| Insulin | -10 minutes to 240 minutes | Measured in serum |
| C-peptide | -10 minutes to 240 minutes | Measured in serum |
| GIP | -10 minutes to 240 minutes | Glucose-dependent insulinotropic polypeptide measured in plasma. |
| PTH | -10 minutes to 240 minutes | PTH measured in serum |
| Glucagon | -10 minutes to 240 minutes | Glucagon measured in plasma |
| Blood pressure | -10 minutes to 240 minutes | Measured before blood sampling |
| Heart rate | -10 minutes to 240 minutes | Measured before blood sampling |
| GLP-2 | -10 minutes to 240 minutes | Glucagon-like peptide 2 measured in plasma. |
| Sclerostin | -10 min to 240 min. | Bone marker. |
Countries
Denmark
Outcome results
None listed