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NCT04782999: BETASIN
Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes
NA trial testing Oral Glucose Tolerance Test in Type2 Diabetes in 9 participants. Completed in 1 March 2022.
1 January 2022
Quick facts
| Lead sponsor | Hvidovre University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 9 |
| Start date | 1 January 2015 |
| Primary completion | 1 January 2022 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Oral Glucose Tolerance Test — full drug profile →
- Hyperglycemic clamp with infusion of saline, GLP-1 or GIP
Conditions studied
- Type2 Diabetes — all drugs for Type2 Diabetes →
- Obesity, Morbid — all drugs for Obesity, Morbid →
Sponsor
Hvidovre University Hospital
Who can join
Adults 18 to 65, any sex, with Type2 Diabetes or Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Insulinotropic effects of GLP-1 and GIP
Time frame: Change from before to 1 week and 3 months after RYGB
Insulin secretion during steady state of all hyperglycemic clamps -
Insulin secretion during oral stimulation
Time frame: Change from before to 3 month after RYGB
AUC of C-peptide during oral glucose tolerance test -
Insulin secretion during iv stimulation
Time frame: Change from before to 1 week and 3 months after RYGB
Insulin secretion during hyperglycemic clamp with saline infusion and during argininine iv stimulation test
Sponsor's own description
The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes. Primary hypotheses: * After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect). * After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively. * After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
· 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
Verify or expand the search:
- PubMed search for NCT04782999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hvidovre University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04782999 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hvidovre University Hospital
- Last refreshed: 14 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04782999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing