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Completed

NCT Number: NCT03867656

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Bone Diseases Bone Resorption Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-2

Other

GLP-2 injection

GIP

Other

GIP injection

Placebo

Other

Placebo injection

Primary outcomes

  1. CTX

    Time frame: -10 minutes to 240 minutes

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

  2. P1NP

    Time frame: -10 minutes to 240 minutes

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

Secondary outcomes

  1. PTH

    Time frame: -10 minutes to 240 minutes

    PTH measured in serum

  2. Sclerostin

    Time frame: -10 min to 240 min.

    Bone marker.

  3. Glucose

    Time frame: -10 minutes to 240 minutes

    Measured in serum

  4. Insulin

    Time frame: -10 minutes to 240 minutes

    Measured in serum

  5. C-peptide

    Time frame: -10 minutes to 240 minutes

    Measured in serum

  6. GIP

    Time frame: -10 minutes to 240 minutes

    Glucose-dependent insulinotropic polypeptide measured in plasma.

  7. GLP-2

    Time frame: -10 minutes to 240 minutes

    Glucagon-like peptide 2 measured in plasma.

  8. Glucagon

    Time frame: -10 minutes to 240 minutes

    Glucagon measured in plasma

  9. Blood pressure

    Time frame: -10 minutes to 240 minutes

    Measured before blood sampling

  10. Heart rate

    Time frame: -10 minutes to 240 minutes

    Measured before blood sampling

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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