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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02360878
Date of registration:	28/01/2015
Prospective Registration:	No
Primary sponsor:	Filip Krag Knop
Public title:	The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
Scientific title:	The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
Date of first enrolment:	February 2013
Target sample size:	25
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02360878
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Filip K Knop, MD, Ph.D.
Address:
Telephone:
Email:
Affiliation:	Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Name:	Ulrich Rohde, MD
Address:
Telephone:
Email:
Affiliation:	Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Key inclusion & exclusion criteria

Inclusion Criteria (obese subjects with type 2 diabetes):

- treatment with DJBS

- written informed consent

- antidiabetic monotherapy/or diet

- > 18 years old

- not anemic

Exclusion Criteria (obese subjects with type 2 diabetes):

- antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one
orally administered antidiabetic drug.

- anemia

Inclusion Criteria (obese subjects without type 2 diabetes):

- Treatment with DJBS

- written informed consent

- not anemic

- HbA1c < 6,0% or HbA1c < 6,5% and normal glucose tolerance test and normal fasting
plasma glucose (< 6,0 mM)

Exclusion Criteria (obese subjects without type 2 diabetes):

- HbA1c > 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose
> 6,0 mM

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Type 2 Diabetes

Intervention(s)

Device: EndoBarrier Gastrointestinal Liner

Primary Outcome(s)

Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Secondary Outcome(s)

Change in basal metabolic rate from baseline 26 weeks after implantation [Time Frame: 0, 50, 210 minutes]

Change in gastric emptying from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucagon secretion 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial insulin secretion from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucose form baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial PYY from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation [Time Frame: 0, 30, 60, 90, 120, 180, 240]

Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation [Time Frame: 0, 30, 60, 90, 120, 180, 240]

Change in gallbladder emptying from baseline 52 weeks after implantation [Time Frame: 0, 20, 40, 60, 90, 120, 150, 180]

Change in gastric emptying from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial ghrelin from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in gastric emptying from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in basal metabolic rate from baseline 3 weeks after explantation [Time Frame: 0, 50, 210 minutes]

Change in basal metabolic rate from baseline 52 weeks after implantation [Time Frame: 0, 50, 210 minutes]

Change in gallbladder emptying from baseline 1 week after implantation [Time Frame: 0, 20, 40, 60, 90, 120, 150, 180]

Change in postprandial glucagon secretion 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucose from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial insulin secretion from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial insulin secretion from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in gallbladder emptying from baseline 3 weeks after explantation [Time Frame: 0, 20, 40, 60, 90, 120, 150, 180]

Change in postprandial glucagon secretion 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucose from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial insulin secretion from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial PYY from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in basal metabolic rate from baseline 1 week after implantation [Time Frame: 0, 50, 210 minutes]

Change in gallbladder emptying from baseline 26 weeks after implantation [Time Frame: 0, 20, 40, 60, 90, 120, 150, 180]

Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation [Time Frame: 0, 30, 60, 90, 120, 180, 240]

Change in postprandial ghrelin from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial ghrelin from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial ghrelin from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial PYY from baseline 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial PYY from baseline 3 weeks after explantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in gastric emptying from baseline 52 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucagon secretion 1 week after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in postprandial glucose from baseline 26 weeks after implantation [Time Frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes]

Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation [Time Frame: 0, 30, 60, 90, 120, 180, 240]

Secondary ID(s)

DJBS meal test

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Copenhagen

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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