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SUGAR Trial: Influence of adding a subtotal gastrectomy to laparoscopic gastric bypass surgery on striatal D2/D3 receptor availability. A Single blinded, randomized, single center study.

SUGAR Trial: Influence of adding a subtotal gastrectomy to laparoscopic gastric bypass surgery on striatal D2/D3 receptor availability. A Single blinded, randomized, single center study. - SUGAR trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47736
Enrollment
32
Registered
2015-07-07
Start date
2016-06-22
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extreme overweight Morbidly and Supermorbidly obese Obesity

Interventions

Adding a subtotal gastrectomy to a standard LRYGB.

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 20-65 years Body Mass Index (BMI) of >=45 kg/m2 at the start of the LRYGB trajectory (defined as the first visit to the surgery outpatient clinic of the Spaarne gasthuis) Stable weight defined as not losing or gaining >2% of total body weight 4 weeks prior to inclusion ASA classification1-2 Written informed consent

Exclusion criteria

Exclusion criteria: Positive serology screening for H.Pylori or positive H.Pylori culture after gastroscopy Auto-immune atrophic gastritis (positive antibodies against intrinsic factor and/or anti-parietal cells) Any psychiatric disease (treated or untreated) or eating disorder Revisional LRYGB surgery Drug addiction (present or in medical history) Frequent use of recreational drugs Childhood-onset obesity Untreated thyroid dysfunction American Society of Anaesthetics (ASA) score >=3 Age >65 years Work with radiation Contraindication for MRI (claustrophobia, metal objects etc.) Shift work Smoking Any medical condition except for stable obesity related conditions (except for insulin-treated DM) History of cardiac diseases Insulin use Pregnancy Genetic causes for the supermorbidily obese state

Design outcomes

Primary

MeasureTime frame
Striatal D2/D3 receptor availability and dopamine release as well as whole brain serotonergic activity.

Secondary

MeasureTime frame
Aspects of motivation and impulse control of feeding behaviour (questionnaires and phMRI) Assessment of craving and hunger (questionnaires) Fasting and postprandial acylated ghrelin (IGTT) Glucose metabolism (IGTT) Gut hormones, free fatty acids Body weight loss Feelings of craving and hunger (Questionnaires) Food addiction according to Yale Food Addiction scale General cognitive functioning

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)