NCT00810823

Brief Summary

Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early as 1 - 2 days after surgery and this is before any real weight loss has occurred. This suggest that the remission of the diabetes is due to the direct effect of the operation more that the secondary effect of the weight loss. The reason for the major effect on the glucose metabolism after gastric bypass surgery is still unaccounted for. This PhD. project will try to unveil some of the mechanisms that could explain the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes. The hypothesis of the study is that a factor "X" will course the remission of the diabetes. This factor "X" is related to the anatomic changes of the gastro intestinal tract, by eliminating the foods passage through the distal part of the ventricle and the duodenum, in combination with the Roux- en-Y sling. The PhD. project will consist of clinical trails on patients that will undergo gastric bypass surgery. The studies will take place before and within the 1. week after surgery. The investigators will measure different hormones and adipokines in fast and the postprandial state. To discover possible new proteins the investigators will run proteomic on some samples. All the results will be compared to the same parameter on patients undergoing gastric banding, where the anatomy of the intestine hasn't been changed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 6, 2011

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

December 17, 2008

Last Update Submit

July 5, 2011

Conditions

Type 2 Diabetes

Keywords

Diabetesgastric bypasstype 2 diabetes and gastric bypass

Outcome Measures

Primary Outcomes (1)

  • What is the factor "X" that cause the remission of type 2 diabetes after gastric bypass

    about 3 years

Study Arms (2)

1:Gastric bypass/diabetes

Patients undergoing gastric bypass surgery, and who are diagnosed with type 2 diabetes.

2:Gastric bypass/not Diabetic

Patients undergoing gastric bypass surgery, not diagnosed with diabetes.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patiens undergoing gastric bypass surgery with or without type 2 diabetes and patients with diabetes undergoing gastric banding

You may qualify if:

  • Well treated hypertension \< 145/85. HbA1C \<8,5 % and c-peptid\> 700pmol/l

You may not qualify if:

  • In treatment with antidepressive, DPP-4 inhibitors and intreatment for thyroid problems.
  • Patients treated with insulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

  • Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.

    PMID: 27306058DERIVED

  • Jorgensen NB, Dirksen C, Bojsen-Moller KN, Kristiansen VB, Wulff BS, Rainteau D, Humbert L, Rehfeld JF, Holst JJ, Madsbad S, Clausen TR. Improvements in glucose metabolism early after gastric bypass surgery are not explained by increases in total bile acids and fibroblast growth factor 19 concentrations. J Clin Endocrinol Metab. 2015 Mar;100(3):E396-406. doi: 10.1210/jc.2014-1658. Epub 2014 Dec 23.

    PMID: 25536209DERIVED

  • Jorgensen NB, Jacobsen SH, Dirksen C, Bojsen-Moller KN, Naver L, Hvolris L, Clausen TR, Wulff BS, Worm D, Lindqvist Hansen D, Madsbad S, Holst JJ. Acute and long-term effects of Roux-en-Y gastric bypass on glucose metabolism in subjects with Type 2 diabetes and normal glucose tolerance. Am J Physiol Endocrinol Metab. 2012 Jul 1;303(1):E122-31. doi: 10.1152/ajpendo.00073.2012. Epub 2012 Apr 24.

    PMID: 22535748DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

January 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 6, 2011

Record last verified: 2008-12

Locations

DK(1)