Clinical trial NCT02360878: The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
Official title: The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obesity
Keywords: DJBS
Duodenal-jejunal bypass sleeve
Duodenal-jejunal bypass liner
Endobarrier
Obesity
Type 2 diabetes
Incretin hormones
Postprandial glucose metabolism
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-02-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial

Brief summary: We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.

Detailed description: Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.

Eligibility 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

Primary outcomes:
measure: Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Secondary outcomes:
measure: Change in basal metabolic rate from baseline 1 week after implantation
timeFrame: 0, 50, 210 minutes
measure: Change in basal metabolic rate from baseline 26 weeks after implantation
timeFrame: 0, 50, 210 minutes
measure: Change in basal metabolic rate from baseline 52 weeks after implantation
timeFrame: 0, 50, 210 minutes
measure: Change in basal metabolic rate from baseline 3 weeks after explantation
timeFrame: 0, 50, 210 minutes
measure: Change in gastric emptying from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in gastric emptying from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in gastric emptying from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in gastric emptying from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in gallbladder emptying from baseline 1 week after implantation
timeFrame: 0, 20, 40, 60, 90, 120, 150, 180
measure: Change in gallbladder emptying from baseline 26 weeks after implantation
timeFrame: 0, 20, 40, 60, 90, 120, 150, 180
measure: Change in gallbladder emptying from baseline 52 weeks after implantation
timeFrame: 0, 20, 40, 60, 90, 120, 150, 180
measure: Change in gallbladder emptying from baseline 3 weeks after explantation
timeFrame: 0, 20, 40, 60, 90, 120, 150, 180
measure: Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation
timeFrame: 0, 30, 60, 90, 120, 180, 240
measure: Change in postprandial insulin secretion from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial insulin secretion from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial insulin secretion from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial insulin secretion from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon secretion 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon secretion 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon secretion 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucagon secretion 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucose from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucose from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucose from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucose form baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial PYY from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial PYY from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial PYY from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial PYY from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial ghrelin from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial ghrelin from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial ghrelin from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial ghrelin from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
measure: Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Other outcomes:
measure: Change in gut microbiota as measured by DNA sequencing from baseline
timeFrame: 52 weeks
measure: Change in body composition from baseline 26 weeks after implantation
timeFrame: 1
measure: Change in body composition from baseline 52 weeks after implantation
timeFrame: 1
measure: Change in caloric intake as measured by ad libitum meal test 1 week after implantation
timeFrame: 30 minutes
measure: Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation
timeFrame: 30 minutes
measure: Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation
timeFrame: 30 minutes
measure: Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation
timeFrame: 30 minutes
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Study officials:
affiliation: Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
name: Filip K Knop, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
name: Ulrich Rohde, MD
role: PRINCIPAL_INVESTIGATOR
References: