Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery

Hvidovre University Hospital

Status: Completed

Conditions: Severe Obesity

Treatments: Drug: exendin 9-39; Drug: sitagliptin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02336659

MSV-14

Details and patient eligibility

About

The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.

Full description

To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose <7.0 mM and HbA1c < 48 mmol/mol 3 month after RYGB.

Exclusion criteria

• Fasting plasma glucose >7.0 mM and HbA1c > 48 mmol/mol 3 month after RYGB. Hemoglobin <6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
• Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 4 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Mixed meal test and ad libitum meal test duing infusion of saline

Treatment:

Other: Placebo

Exendin 9-39

Experimental group

Description:

Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min

Treatment:

Drug: exendin 9-39

DPP-4 Inhibition

Experimental group

Description:

Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg \* 2

Treatment:

Drug: sitagliptin

Exendin 9-39 / DPP 4-Inhibition

Experimental group

Description:

Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg \* 2

Treatment:

Drug: sitagliptin

Drug: exendin 9-39