Weight-loss and Gut-brain Interactions

NCT01740050 | Unknown

• 1 other identifier: NL42676.068.12
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

While exposure to an obesogenic environment has increased for almost every individual in western society, not everyone is equally susceptible to overeating and not everyone becomes obese. Teasing apart the physiological underpinnings of those individual seemingly protective- differences may contribute to the development of successful preventive measures and treatment. Neuroimaging studies started to deliver important insights into the neuroanatomical determination of individual eating behavior. However, food intake is not only determined by the brain, but is orchestrated by an interaction of peripheral hormones with neural circuits and decision-making processes. This interactive axis is also referred to as the gut-brain axis. While individual aspects of the axis have been studied extensively, detailed insight in the interaction of gut and brain in the regulation of food intake is lacking. Objective: The current study aims to investigate the effect of a) caloric restriction (very low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on gut-brain interactions to find an optimal balance for weight loss and long-term sustained weight maintenance.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• the optimal interaction of gut hormones and brain activity

  To determine the optimal interaction of gut hormones and brain activity, resulting in successful weight loss and sustained weight maintenance. This objective will be investigated by examining the effect of a) caloric restriction (VLCD); b) caloric restriction with mechanical restriction (LAGB); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (RYGB) on food reward processing and decision-making in the brain and on gastrointestinal hormone release. The main parameters contributing to efficient, effective and satisfactorily weight maintenance at the same time is the change in satiety and in food reward upon an iso-energetic test-meal. This will be the main factor contributing to compliance and preventing reversal, (measured by visual analog scales (VAS), changes in ad libitum meal intake, representation in the brain of food reward processing and decision making, computer test, TFEQ for cognitive restraint, disinhibition and hunger).

  30 to 60 days: At baseline and after weight loss (10% of initial weight)

Secondary Outcomes (4)

• gut-microbiota

  30 to 60 days: At baseline and after weight loss (10% of initial weight)

• body composition

  30 to 60 days: At baseline and after weight loss (10% of initial weight)

• endocannabinoid profile

  30 to 60 days: At baseline and after weight loss (10% of initial weight)

• Diet induced energy expenditure

  30 to 60 days: At baseline and after weight loss (10% of initial weight)

Study Arms (3)

Roux- and Y bypas surgery (RYGB)

ACTIVE COMPARATOR

One subject group will lose 10% of initial body weight using RYGB. RYGB is an operation that first divides the stomach into a small upper pouch and a much larger lower "remnant" pouch and then re-arranges the small intestine to connect to both, in this way bypassing part of the small intestine.

Procedure: RYGB

Laparoscopic adjustable gastric banding (LAGB)

ACTIVE COMPARATOR

One subject group will lose 10% of initial body weight using LAGB. With LAGB an inflatable band is placed around the upper part of the stomach to create a smaller stomach pouch. This slows and limits the amount of food that can be consumed at one time giving the opportunity for the sense of satiety to be met. It does not decrease gastric emptying time.

Procedure: LAGB

Very Low Calorie Diet (VLCD)

ACTIVE COMPARATOR

One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.

Dietary Supplement: Very Low Calorie Diet (VLCD)

Interventions

Very Low Calorie Diet (VLCD) DIETARY_SUPPLEMENT

One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.

Very Low Calorie Diet (VLCD)

RYGB PROCEDURE

Roux- and Y bypas surgery (RYGB)

LAGB PROCEDURE

Laparoscopic adjustable gastric banding (LAGB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subject has a body mass index (BMI) of 40 - 45 or 35 to 39.9 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.
• Subject must be of sufficient and stable medical health, as evaluated by physician at intake.
• Subject 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.

You may not qualify if:

• \- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease, as evaluated by physician at intake for the surgery.
• 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, as evaluated by physician at intake.
• Subject has thyroid disease, which is not controlled with medication, as evaluated by physician at intake for the surgery.
• 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.
• Subjects who have cardiac pacemakers or other electronic implantable devices.
• Subjects who have psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
• Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
• Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
• Presence of contra-indications for f-MRI, as mentioned in the screening form and informed consent of the faculty of psychology (see section E2 and F1).
• Claustrophobia

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University (metabolic research unit Maastricht (MRUM))

Maastricht, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja C Adam, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mieke JI Martens, Phd

CONTACT

0031433882124; mieke.martens@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

NL (1)