The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes
1 other identifier
observational
20
1 country
1
Brief Summary
Gastric bypass surgery induces remission of diabetes within days after surgery, before significant weight loss. The aim of the study is to examine whether improved insulin sensitivity of muscle and liver contributes to the immediate diabetes resolution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedOctober 25, 2013
October 1, 2013
2.5 years
September 15, 2010
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity after RYGB
1 week, 3 months, 1 year
Secondary Outcomes (1)
Change in insulin secretion in response to oral glucose after RYGB
3 months, 1 year
Other Outcomes (1)
Change in insulin secretion after iv glucose-glucagon after RYGB
1 week, 3months, 1 year
Study Arms (2)
RYGB patients with type 2 diabetes
Morbid obese patients with type 2 diabetes undergoing gastric bypass surgery
RYGB patients without type 2 diabetes
Morbid obese patients with normal glucose tolerance undergoing gastric bypass surgery
Eligibility Criteria
Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital
You may qualify if:
- patients eligible for gastric bypass surgery
- Verified type 2 diabetes or normal glucose tolerance by oral glucose tolerance test (OGTT)
You may not qualify if:
- Treatment for Hyperthyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- University of Copenhagencollaborator
Study Sites (1)
Hvidovre University Hospital
Copenhagen, Hvidovre, DK-2650, Denmark
Related Publications (2)
Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.
PMID: 24891019DERIVEDBojsen-Moller KN, Dirksen C, Jorgensen NB, Jacobsen SH, Serup AK, Albers PH, Hansen DL, Worm D, Naver L, Kristiansen VB, Wojtaszewski JF, Kiens B, Holst JJ, Richter EA, Madsbad S. Early enhancements of hepatic and later of peripheral insulin sensitivity combined with increased postprandial insulin secretion contribute to improved glycemic control after Roux-en-Y gastric bypass. Diabetes. 2014 May;63(5):1725-37. doi: 10.2337/db13-1307. Epub 2013 Nov 15.
PMID: 24241533DERIVED
Biospecimen
serum, plasma, urine, muscle, subcutaneous fat, visceral fat
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Kirstine Bojsen-Møller, MD
Hvidovre University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 25, 2013
Record last verified: 2013-10