NL-OMON43908
Recruiting
Not Applicable
Effect of weight status and different weight-loss methods on gut-brain interactions - Weight, Weight-loss and gut-brain interactions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesitas
- Sponsor
- niversiteit Maastricht
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to be included in the RYGB subject group of this study, a subject must qualify for weight loss surgery with RYGB, as evaluated by a physician at intake for surgery.
- •Furthermore, ALL subjects (RYGB, VLCD and Control) must meet all of the following criteria:
- •\- Subject, male or female, is age 18 to 60 years of age.
- •\- Subject must be able to understand and be willing to sign an informed consent document.
- •\- Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study.
- •\- For the RYGB group: subject has a body mass index (BMI) of 30 to 45 plus one or more co\-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus, as evaluated by physician at intake. For the VLCD and control group: subject has a BMI of \> 30 \* 45\.
- •\- Subject must be of sufficient and stable medical health, as evaluated by physician at intake.
- •\- Subjects included in the RYGB subject group must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed at the intake for surgery by a physician.
- •\- For the fMRI measurements inclusion criteria are as follows: not having any metallic fragments in the body, being right\-handed. Because of the different brain laterality in left\- and right\-handed subjects we chose to include only right\-handed subjects. Hence the results can be compared between the subjects.
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •\- Subject has history of/or signs and/or symptoms of gastro\-duodenal ulcer disease, by physician at intake.
- •\- Subject has had significant weight loss in the last 3 months (\>5kg).
- •\- Subject has a history or is diagnosed with eating disorders.
- •\- Subject has renal and/or hepatic insufficiency, by physician at intake.
- •\- Subject has thyroid disease, which is not controlled with medication, as evaluated by physician at intake.
- •\- Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- •\- Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study.
- •\- Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the start of the study as well as during the trial period.
- •\- Subjects who have started medications within the last 3 months that are known to cause weight gain.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Effects of weight loss program with different rate and duration before competition on stress responses and athletic performanceormalJPRN-UMIN000049195Takasaki University of Health and Welfare30
Completed
Not Applicable
The effects of equivalent weight loss with or without exercise programme on breast cancer risk biomarkers in postmenopausal women: the SHAPE-2 study.breast cancerbreast neoplasm10006291NL-OMON38377niversitair Medisch Centrum Utrecht250
Completed
Not Applicable
Suppression effects on body weight and fat of calcium alginate in healthy adultsmetabolic syndromeJPRN-UMIN000019658Takasaki University of Health and Welfare10
Recruiting
Not Applicable
Effect of weight change and recovery status according to nutritional of supplement intake in gastric cancer patients: A prospective, randomized, open-label, control comparative clinical trialNeoplasmsKCT0005762Soon Chun Hyang University Hospital Bucheon56
Completed
Not Applicable
ong-Term Effect of Goal directed weight management on Atrial Fibrillation Cohort: A 5 Year follow-up studyAtrial Fibrillation burdenobesityCardiovascular - Other cardiovascular diseasesDiet and Nutrition - ObesityACTRN12614001123639Adelaide University356