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

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ClinicalTrials.gov Identifier: NCT03867656
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Kirsa Skov-Jeppesen, University of Copenhagen

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : December 26, 2019
Estimated Study Completion Date : December 26, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. CTX [ Time Frame: -10 min to 240 min ]
    Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

  2. P1NP [ Time Frame: -10 min to 240 min ]
    Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.


Secondary Outcome Measures :
  1. PTH [ Time Frame: -10 min to 240 min. ]
    PTH measured in serum

  2. Sclerostin [ Time Frame: -10 min to 240 min. ]
    Bone marker.

  3. Glucose [ Time Frame: -10 min to 240 min. ]
    Measured in serum

  4. Insulin [ Time Frame: -10 min to 240 min. ]
    Measured in serum

  5. C-peptide [ Time Frame: -10 min to 240 min. ]
    Measured in serum

  6. GIP [ Time Frame: -10 min to 240 min. ]
    Glucose-dependent insulinotropic polypeptide measured in plasma.

  7. GLP-2 [ Time Frame: -10 min to 240 min. ]
    Glucagon-like peptide 2 measured in plasma.

  8. Glucagon [ Time Frame: -10 min to 240 min. ]
    Glucagon measured in plasma

  9. Blood pressure [ Time Frame: -10 min to 240 min. ]
    Measured before blood sampling

  10. Heart rate [ Time Frame: -10 min to 240 min. ]
    Measured before blood sampling



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Age 25 to 65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867656


Contacts
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Contact: Kirsa Skov-Jeppesen, Cand.pharm. 26818619 kirsa@sund.ku.dk
Contact: Mette Rosenkilde

Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Sten Madsbad, MD         
Contact: Kirsa Skov-Jeppesen         
Principal Investigator: Kirsa Skov-Jeppesen, Cand.pharm         
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Investigators
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Study Director: Mette Rosenkilde, MD University of Copenhagen

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Responsible Party: Kirsa Skov-Jeppesen, Principal Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03867656     History of Changes
Other Study ID Numbers: KS-4-Diabetes-19
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kirsa Skov-Jeppesen, University of Copenhagen:
Type 2 Diabetes Mellitus
Bone resorption
Bone formation
CTX
P1NP
GLP-2
GIP
Bone turnover
Bone remodeling

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins