Physiological Effects of Gastric Sleeve Operation

Obesity, Morbid Clinical Trial

Official title:

Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046186
• Other study ID #: MS-SGRYGB-15
• Status: Completed
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity, Morbid

Intervention

Diagnostic Test:
• Mixed meal test with double tracer technique

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose absorption	Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON	0 - 360 minutes
Primary	Protein absorption	Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON	0 - 360 minutes
Secondary	Glucose absorption	Between group difference in peak Ra of oral glucose comparing SG vs. RYGB	0 - 360 minutes
Secondary	Protein absorption	Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB	0 - 360 minutes
Secondary	Glucose kinetics	Between groups differences in AUC Ra of oral glucose tracer	0 - 360 minutes
Secondary	Protein kinetics	Between groups differences in AUC Ra of oral aminoacid tracer	0 - 360 minutes
Secondary	Insulin secretion	Between groups differences in iAUC of serum insulin and C-peptide	0 - 240 minutes
Secondary	Glucagon-like Peptide 1 (GLP-1) secretion	Between groups differences in iAUC of plasma concentration of GLP-1	0 - 240 minutes
Secondary	Glucose-dependent Insulinotropic Peptide (GIP)	Between groups differences in iAUC of plasma concentration of GIP	0 - 240 minutes
Secondary	Ghrelin secretion	Between groups differences in iAUC of plasma concentration of ghrelin	0 - 240 minutes
Secondary	Glucagon secretion	Between groups differences in iAUC of plasma cncentration of glucagon	0-240 minutes
Secondary	Peptide YY	Between groups differences in iAUC of plasma concentration of PYY	0-240 minutes
Secondary	Endogenous glucose production	Calculated via double tracer tecnique both in the fasting and post prandial state.	-120 - 360 minutes
Secondary	Lipolysis	Between groups differences in Rate of Disappearance of glycerol tracer.	-120 - 360