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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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25 March 2019 |
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Main ID: |
ISRCTN11764561 |
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Date of registration:
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03/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Characterization of the incretin response and microbiota following bariatric surgery, and its role for weight loss – a search for polytherapeutic strategies to combat obesity and ultimately rival surgery
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Scientific title:
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Characterization of the incretin response and microbiota in women before an after bariatric surgery, aiming to determine how the microbiota regulates metabolism, and its role for weight loss: a randomized controlled trial |
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Date of first enrolment:
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27/02/2017 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://isrctn.com/ISRCTN11764561 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Camilla
Krizhanovskii |
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Address:
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Lagmansvägen 15
15286
Södertälje
Sweden |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Obese non-diabetic females
2. 18-65 years of age
3. Signed informed consent form
Exclusion criteria:
1. Type 2 diabetes
2. Any history of receiving GLP-1 analogues or DPP-4 inhibitors
3. Previous treatment with insulin (any regimen) within 3 months
4. Current or history of drug and alcohol abuse
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obesity
Nutritional, Metabolic, Endocrine
Obesity
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Intervention(s)
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Non-diabetic patients with severe obesity (that is, BMI >40 kg/m. or BMI >35 kg/m. with comorbidities) will be randomized into two groups receiving either gastric bypass (RYGB) or gastric sleeve. Patients will be followed for 6 months post-surgery, and fecal and blood samples will be collected before surgery, as well as 3 and 6 months after surgery. Meal stimulated GLP-1 plasma levels will be determined prior to and 3 and 6 months after surgery. The primary endpoint is the proportion of subjects achieving a 15% relative change in meal stimulated GLP-1 plasma levels following gastric bypass surgery (RYGB)/gastric sleeve compared to pre-surgical meal stimulated GLP-1 release, as assessed by GLP-1 specific ELISA of serum samples. Secondary endpoints are whether a 15% weight reduction of presurgical body weight is observed following gastric bypass surgery (RYGB)/sleeve.
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Primary Outcome(s)
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1. Plasma GLP-1, measured using the meal tolerance test and GLP-1 specific ELISA of serum samples
2. Gut microbiota composition, analyzed from fecal samples
Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery
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Secondary Outcome(s)
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1. Plasma inflammatory markers, analyzed by specific ELISAs
2. Lipid profile, determined by commercially available HDL and LDL/VLDL Cholesterol Assay Kits, Free Fatty Acid Quantification Kit, as well as Triglyceride Quantification Kit
Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery
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Source(s) of Monetary Support
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Mats Kleberg Foundation, Fredrik och Ingrid Thurings Stiftelse, Tore Nilsons Stiftelse för Medicinsk Forskning
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Ethics review
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Status:
Approval date:
Contact:
Regionala etikprövningsnämnden i Stockholm (regional ethics board in Stockholm), 26/08/2015, ref: 2015/795-31/2
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/09/2020 |
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URL:
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