Hypothalamic Function Before and After Bariatric Surgery

Hypothalamic Morphology, Neuronal Activity and Systems Biology in Response to Food Intake in Obese Patients With Type 2 Diabetes Mellitus Compared to Obese and Lean Controls

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01167959

Enrollment

Registered

2010-07-22

Start date

2009-06-30

Completion date

2012-05-31

Last updated

2012-12-24

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

Conditions

Diabetes, Obesity

Keywords

Obesity, Diabetes, Bariatric surgery

Brief summary

The purpose of this study is to determine the effect of gastric banding or gastric bypass on hypothalamic morphology and function, gut hormones and systems biology in obese subjects with and without type 2 diabetes.

Interventions

PROCEDURERoux en Y gastric bypass and lap. gastric banding

Standard RYGB and LAGB procedures

BEHAVIORALProdimed dietary intervention

3 months of using the prodimed diet

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients aged 35-65 years; * BMI \> 40 kg/m2; * BMI \> 35 and \<40 kg/m2 with co-morbidity, which is expected to improve after surgically-induced weight loss; * A history of longstanding obesity (\>5 years); * Proven failed attempts to lose weight in a conventional way, or primarily successful weight loss with eventual weight regain; * Intention to adhere to a postoperative follow-up programme.

Exclusion criteria

* BMI\> 50 or body weight \> 150 kg (because it is impossible to safely put people above this weight on a standard table for MRI); * Subjects with disease related obesity, i.e. Cushing or medication related obesity; * Use of medication known to affect glucose or lipid metabolism (i.e. prednisone) * Monogenetic diabetes: MODY, Mitochondrial diabetes; * LADA (adult-onset latent autoimmune diabetes); detected by c-peptide measurement on screening. * Impaired renal function (serum creatinine \> 176 μmol/L); * Leg ulcers, gangrene. * Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting the brain * Any significant chronic disease * Renal or hepatic disease * Pregnancy * Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months) * Aerobic exercise more that 3 times 60 minutes a week * Alcohol consumption of more than 28 units per week at present or in the past * Recent blood donation (within the last 2 months) * Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year * Contra-indications to operative procedures as regular in bariatric surgery * Contra-indications to MRI scanning

Design outcomes

Primary

Measure	Time frame
Changes in gut hormones	3 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026