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

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03867656
• Collaborator: Hvidovre University Hospital (Other)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 16
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Other: GLP-2; Other: GIP; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Jun 26, 2020
• Actual Study Completion Date: Jun 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GLP-2 Glucagon-like peptide 2	Other: GLP-2; GLP-2 injection
Experimental: GIP Glucose-dependent insulinotropic polypeptide	Other: GIP; GIP injection
Placebo Comparator: Placebo Saline	Other: Placebo; Placebo injection

Outcome Measures

Primary Outcome Measures

1. CTX [-10 minutes to 240 minutes]

   Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

2. P1NP [-10 minutes to 240 minutes]

   Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.

Secondary Outcome Measures

1. PTH [-10 minutes to 240 minutes]

   PTH measured in serum

2. Sclerostin [-10 min to 240 min.]

   Bone marker.

3. Glucose [-10 minutes to 240 minutes]

   Measured in serum

4. Insulin [-10 minutes to 240 minutes]

   Measured in serum

5. C-peptide [-10 minutes to 240 minutes]

   Measured in serum

6. GIP [-10 minutes to 240 minutes]

   Glucose-dependent insulinotropic polypeptide measured in plasma.

7. GLP-2 [-10 minutes to 240 minutes]

   Glucagon-like peptide 2 measured in plasma.

8. Glucagon [-10 minutes to 240 minutes]

   Glucagon measured in plasma

9. Blood pressure [-10 minutes to 240 minutes]

   Measured before blood sampling

10. Heart rate [-10 minutes to 240 minutes]

    Measured before blood sampling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre		Denmark	2650

Sponsors and Collaborators

• University of Copenhagen
• Hvidovre University Hospital

Investigators

• Study Director: Mette Rosenkilde, MD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kirsa Skov-Jeppesen, Principal Investigator, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT03867656
• Other Study ID Numbers: KS-4-Diabetes-19
• First Posted: Mar 8, 2019
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kirsa Skov-Jeppesen, Principal Investigator, University of Copenhagen: Type 2 Diabetes Mellitus; Bone resorption; Bone formation; CTX; P1NP; GLP-2; GIP; Bone turnover; Bone remodeling
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 4, 2020