Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: GLP-2
* Other: GIP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-2<br>Glucagon-like peptide 2 | Other: GLP-2<br>* GLP-2 injection<br>|
| Experimental: GIP<br>Glucose-dependent insulinotropic polypeptide | Other: GIP<br>* GIP injection<br>|
| Placebo Comparator: Placebo<br>Saline | Other: Placebo<br>* Placebo injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTX | Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum. | -10 minutes to 240 minutes | 
| P1NP | Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum. | -10 minutes to 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH | PTH measured in serum | -10 minutes to 240 minutes | 
| Sclerostin | Bone marker. | -10 min to 240 min. | 
| Glucose | Measured in serum | -10 minutes to 240 minutes | 
| Insulin | Measured in serum | -10 minutes to 240 minutes | 
| C-peptide | Measured in serum | -10 minutes to 240 minutes | 
| GIP | Glucose-dependent insulinotropic polypeptide measured in plasma. | -10 minutes to 240 minutes | 
| GLP-2 | Glucagon-like peptide 2 measured in plasma. | -10 minutes to 240 minutes | 
| Glucagon | Glucagon measured in plasma | -10 minutes to 240 minutes | 
| Blood pressure | Measured before blood sampling | -10 minutes to 240 minutes | 
| Heart rate | Measured before blood sampling | -10 minutes to 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover, Bone remodeling