Effects of Gut Peptides on Bone Remodeling

Study Overview
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Brief Summary
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We will investigate effects of gut hormones on bone remodeling.

Official Title
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Investigation of GLP-2 Mechanism of Action

Conditions
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Healthy

Intervention / Treatment
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* Other: Glucagon-Like Peptide-2 (GLP-2)
* Other: Glucose-dependent insulinotropic polypeptide (GIP)
* Other: GLP-2+GIP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Age above 50 years Postmenopausal Caucasian BMI 18.5 to 28.0 kg/m2. Exclusion Criteria: Smoking Medication believed to influence study outcome Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<7,0 mmol/L Decreased renal function

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-2<br>Glucagon-Like Peptide-2 (GLP-2) | Other: Glucagon-Like Peptide-2 (GLP-2)<br>* Glucagon-Like Peptide-2 (GLP-2) injection.<br>|
| Experimental: GIP<br>Glucose-dependent Insulinotropic polypeptide (GIP) | Other: Glucose-dependent insulinotropic polypeptide (GIP)<br>* Glucose-dependent insulinotropic polypeptide (GIP) injection.<br>|
| Experimental: GLP-2+GIP<br>GLP-2+GIP | Other: GLP-2+GIP<br>* GLP-2+GIP injection.<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-terminal telopeptide (CTX). At all time points and AUC(0-240 min). | CTX is a marker of bone resorption. Measured in serum. | -10 minutes to 600 minutes | 
| N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min). | P1NP is a marker of bone formation. Measured in serum. | -10 minutes to 600 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH | Bone marker. Measured in serum. | -10 minutes to 600 minutes | 
| Sclerostin | Bone marker. | -10 minutes to 600 minutes | 
| Calcium | Measured in serum within 5 days. | -10 minutes to 600 minutes | 
| Glucose | Measured in serum. | -10 minutes to 600 minutes | 
| Glucose-dependent insulinotropic polypeptide (GIP) | Total and intact GIP. Measured in plasma. | -10 minutes to 600 minutes | 
| Insulin | Measured in serum. | -10 minutes to 600 minutes | 
| C-peptide | Measured in serum. | -10 minutes to 600 minutes | 
| Glukagon-like peptide-1 (GLP-1) | Measured in plasma. | -10 minutes to 600 minutes | 
| Glucagon | Measured in plasma. | -10 minutes to 600 minutes | 
| Glukagon-like peptide-2 (GLP-2) | Intact GLP-2. Measured in plasma. | -10 minutes to 600 minutes | 
| PP | Measured in plasma. | -10 minutes to 600 minutes |