## Protocol Section
### Identification Module
**NCT ID:** NCT01559779

**Acronym:** AB-CD-10

**Brief Title:** Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

**Official Title:** The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

#### Organization Study ID Info
**ID:** AB-CD-10
#### Organization
**Class:** OTHER
**Full Name:** Hvidovre University Hospital
### Status Module
#### Completion Date
**Date:** 2012-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-06-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-06-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Start Date
**Date:** 2010-11

**Status Verified Date:** 2014-06

#### Study First Post Date
**Date:** 2012-03-21
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-19
**Study First Submit QC Date:** 2012-03-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Copenhagen

#### Lead Sponsor

**Class:** OTHER

**Name:** Hvidovre University Hospital

#### Responsible Party

**Investigator Affiliation:** Hvidovre University Hospital

**Investigator Full Name:** Carsten Dirksen

**Investigator Title:** MD PhD student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- Obesity

- Roux-en-Y gastric bypass

- Incretin hormones

- Beta cell function

### Design Module

#### Bio Spec

**Description:** Plasma and serum specimens are retained

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 11

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery

**Label:** Normal glucose tolerance

### Outcomes Module

#### Primary Outcomes

**Description:** Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus

**Measure:** Change in beta cell function

**Time Frame:** Before and 1 week and 3 months after surgery

**Description:** Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline

**Measure:** Insulinotropic effect of incretin hormones

**Time Frame:** Before and 1 week and 3 months after surgery

#### Secondary Outcomes

**Description:** Change in glucagon secretion in response to glucose and non-glucose stimuli

**Measure:** Change in alpha cell function

**Time Frame:** Before and 1 week and 3 months after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Normal glucose tolerance
* Age \> 18 years
* BMI \> 40 or \> 35 if combined with hypertension or obstructive sleep apnoea
* Caucasian
* Normal hemoglobinaemia
* Signed informed consent

Exclusion Criteria:

* Major psychiatric disorder
* Alcohol or drug abuse
* Major hearth or pulmonary disease
* Previous major abdominal disease (e.g. peritonitis, large hernia)
* Pregnancy/lactation
* Treatment with GLP-1 analogs

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hvidovre

**Country:** Denmark

**Facility:** Dpt. of Endocrinology (215) at Hvidovre Hospital

**State:** Copenhagen

**Zip:** 2650

#### Overall Officials

**Official 1:**

**Affiliation:** Hvidovre University Hospital

**Name:** Carsten Dirksen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Dirksen C, Bojsen-Moller KN, Jorgensen NB, Jacobsen SH, Kristiansen VB, Naver LS, Hansen DL, Worm D, Holst JJ, Madsbad S. Exaggerated release and preserved insulinotropic action of glucagon-like peptide-1 underlie insulin hypersecretion in glucose-tolerant individuals after Roux-en-Y gastric bypass. Diabetologia. 2013 Dec;56(12):2679-87. doi: 10.1007/s00125-013-3055-1. Epub 2013 Sep 19.

**PMID:** 24048673

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M8866

- Name: Gastric Inhibitory Polypeptide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
