Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03950245
Other study ID # MH-INKA-BAR-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date April 16, 2021

Study information

Verified date January 2022
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 16, 2021
Est. primary completion date April 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria, surgery groups: - Age > 18 years - RYGB or SG operation > 12 months prior to inclusion - Weight stable (± 3 kg during the last month) - HbA1c < 48 mmol/mol before surgery, and no history of diabetes - HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion Inclusion Criteria, control group: - Age > 18 years - no former RYGB- or SG operation - Weight stable (± 3 kg during the last month) - HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1 mmol/l and no history of diabetes Exclusion Criteria: - Thyrotoxicosis or inadequately treated hypothyreosis - Hemoglobin < 6.5 mmol/l at inclusion - Pregnancy or breast feeding - Medication affecting the planned examinations Matching between groups - Age - Sex - BMI at inclusion and for surgery groups also pre-surgery BMI

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Locations

Country Name City State
Denmark Department of Endocrinology Hvidovre
Denmark Hvidovre Hospital Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary iAUC glucose Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group 240 minutes
Secondary Beta-cell glucose sensitivity (ß-GS) Main comparison between groups: delta ß-GS (ß-GS exendin(9-39) test day - ß-GS GIP(3-30) test day) in the RYGB group compared to the SG group 240 minutes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04433338 - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery N/A
Completed NCT05854875 - Diabetes Remission After RYGBP and RYGBP With Fundus Resection N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Enrolling by invitation NCT02552433 - Complications in Body Contouring Surgery
Completed NCT02525016 - Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery Phase 3
Recruiting NCT01984762 - Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. N/A
Not yet recruiting NCT01652105 - Randomized Trial of Preoperative Diets Before Bariatric Surgery N/A
Completed NCT00989157 - Effects of Gastric Bypass on Blood Levels of Duloxetine Phase 3
Completed NCT03609632 - Understanding Hypoglycaemia After Bariatric Surgery N/A
Completed NCT05454696 - Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Recruiting NCT04297306 - Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery N/A
Recruiting NCT05428618 - Mobile Application for Bariatric Surgery Patients N/A
Not yet recruiting NCT03900481 - Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity N/A
Not yet recruiting NCT03975244 - Semi-supervised Exercise Program Before Bariatric Surgery N/A
Recruiting NCT06170749 - Prediction Model for Anemia After Bariatric Surgery