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Clinical Trial NCT06194955 (H-21044858) for Incretin Effect is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of CopenhagenThe Effect of GIP, GLP-1 and GLP-2 in Individuals With Genetically Altered Receptor Function (H-21044858) 60
Clinical Trial NCT06194955 (H-21044858) is an interventional study for Incretin Effect that is recruiting. It started on January 4, 2023 with plans to enroll 60 participants. Led by University of Copenhagen, it is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on May 7, 2024.
Brief Summary
This project will characterize the physiological effect of the hormones, GIP-, GLP-1- and GLP-2 infusions in a group of individuals that are carriers of GIP-, GLP-1- and GLP-2 receptor gene variants, respectively.
Detailed Description
Participants with mutations in their GLP-1- and GIP receptor will attend five randomized experimental days, A1, A2, B, C and D. On day A1 an oral glucose tolerance test (OGTT) will be performed, and on day A2, an intravenous isoglycaemic glucose infusion (IIGI) will be performed. On experimental day B and C, the study participants will receive GLP-1 and GIP hormones, respectively, under stable glucose infusions and o...Show More
Official Title
The Effect of Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-like Peptide-1 (GLP-1) and Glucagon-like Peptide-2 (GLP-2) in Individuals With Genetically Altered Receptor Function
Conditions
Incretin EffectOther Study IDs
- H-21044858
NCT ID Number
Start Date (Actual)
2023-01-04
Last Update Posted
2024-05-07
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Gut hormones
single nucleotide variants (SNVs)
GIP
GLP-1
GLP-2
single nucleotide variants (SNVs)
GIP
GLP-1
GLP-2
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGIPR variant carriers Inidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. | GIP(1-42) Infusion GLP-1 Infusion Placebo Saline |
Placebo ComparatorGIPR variant carrier controls Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. | GIP(1-42) Infusion GLP-1 Infusion Placebo Saline |
Active ComparatorGLP-1R variant carrier Individuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp | GIP(1-42) Infusion GLP-1 Infusion Placebo Saline |
Placebo ComparatorGLP-1R variant carrier controls Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp. | GIP(1-42) Infusion GLP-1 Infusion Placebo Saline |
Active ComparatorGLP-2R variant carrier Individuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels | GLP-2 Infusion Placebo Saline |
Placebo ComparatorGLP-2R variant carrier control Healthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels | GLP-2 Infusion Placebo Saline |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide) | Blood sample | 240 minutes |
For GLP-2 receptor variants: CTX (bone resorption marker) | Blood sample | 120 minutes |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
GIP levels | Blood sample | 240 minutes |
GLP-1 levels | Blood sample | 240 minutes |
GLP-2 levels | Blood sample | 240 minutes |
CTX (bone resorption marker) | Blood sample | 240 minutes |
P1NP (bone formation marker) | Blood Sample | 240 minutes |
Heart rate | Beats/minute | 240 minutes |
Insulin | Blood sample | 240 minutes |
Glucagon | Blood sample | 240 minutes |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- BMI 19-35 kg/m2
- Treatment with medication or supplements that can not be discontinued for 12 hours
- >10 objects of alcohol weekly or abuse of narcotics
- Liver disease (defined as ALAT and/or ASAT ≥ 2 x normal levels)
- Decreased kidney function (creatine levels over reference interval)
- Uncontrollable increased blood pressure (> 140/90 mmHg)
- Low blood percentage (hemoglobin < 8.3 mmol/l)
- Special diet or planned weight change during trial period
- Other conditions that could be expected to affect the primary or secondary outcomes
University of Copenhagen220 active studies to exploreGentofte Hospital, DenmarkStudy Central Contact
Contact: Lærke S Gasbjerg, MD, PhD, +45 35322626, [email protected]
Contact: Sheyma Kizilkaya, MSc, +45 40502056, [email protected]
1 Study Locations in 1 Countries
Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, 2900, Denmark
Lærke S Gasbjerg, Contact, [email protected]
Recruiting