Physiological Effects of Gastric Sleeve Operation

Hvidovre University Hospital

Status: Completed

Conditions: Bariatric Surgery; Obesity, Morbid

Treatments: Diagnostic Test: Mixed meal test with double tracer technique

Study type: Observational

Funder types: Other

Identifiers

NCT03046186

MS-SGRYGB-15

Details and patient eligibility

About

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

Enrollment: 36 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

SG ang RYGB group:

Inclusion Criteria:

• Uncomplicated RYGB or SG > 12 month prior to inclusion
• Weight stable (+/- 3 month the last month)
• Written informed consent

Exclusion Criteria:

• Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
• Pregnancy and/or breastfeeding
• Inadequately treated thyroid disease
• Serious heart or respiratory illness
• Haemoglobin < 6,5 mM.

Un-operated control group:

Inclusion Criteria:

• Written informed consent

Exclusion Criteria:

• Prior RYGB, SG or complicated upper gastrointestinal surgery
• Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
• Pregnancy and/or breastfeeding
• Inadequately treated thyroid disease
• Serious heart or respiratory illness
• Haemoglobin < 6,5 mM.

Trial design

36 participants in 3 patient groups

Gastric sleeve operated subjects

Description:

12 patients who have undergone gastric sleeve operation \>12 month prior to inclution.

Treatment:

Diagnostic Test: Mixed meal test with double tracer technique

Control Subjects

Description:

12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age

Treatment:

Diagnostic Test: Mixed meal test with double tracer technique

Gastric bypass operated subjects

Description:

12 patients, who have undergone Roux-en-Y gastric bypass \>12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age.

Treatment:

Diagnostic Test: Mixed meal test with double tracer technique