Hypothalamic Function Before and After Bariatric Surgery
NCT ID: NCT01167959
Last Updated: 2012-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2009-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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obesity diabetes, surgical and dietary
Roux en Y gastric bypass and lap. gastric banding
Standard RYGB and LAGB procedures
Prodimed dietary intervention
3 months of using the prodimed diet
Interventions
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Roux en Y gastric bypass and lap. gastric banding
Standard RYGB and LAGB procedures
Prodimed dietary intervention
3 months of using the prodimed diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
FEMALE
Yes
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Mirjam Anne Lips
drs
Principal Investigators
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Hanno Pijl, MD Phd Proff
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Locations
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Leiden University Medical Centre
Leiden, South Holland, Netherlands
Countries
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References
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Maessen DE, Hanssen NM, Lips MA, Scheijen JL, Willems van Dijk K, Pijl H, Stehouwer CD, Schalkwijk CG. Energy restriction and Roux-en-Y gastric bypass reduce postprandial alpha-dicarbonyl stress in obese women with type 2 diabetes. Diabetologia. 2016 Sep;59(9):2013-7. doi: 10.1007/s00125-016-4009-1. Epub 2016 Jun 16.
Lips MA, Van Klinken JB, van Harmelen V, Dharuri HK, 't Hoen PA, Laros JF, van Ommen GJ, Janssen IM, Van Ramshorst B, Van Wagensveld BA, Swank DJ, Van Dielen F, Dane A, Harms A, Vreeken R, Hankemeier T, Smit JW, Pijl H, Willems van Dijk K. Roux-en-Y gastric bypass surgery, but not calorie restriction, reduces plasma branched-chain amino acids in obese women independent of weight loss or the presence of type 2 diabetes. Diabetes Care. 2014 Dec;37(12):3150-6. doi: 10.2337/dc14-0195. Epub 2014 Oct 14.
Lips MA, Wijngaarden MA, van der Grond J, van Buchem MA, de Groot GH, Rombouts SA, Pijl H, Veer IM. Resting-state functional connectivity of brain regions involved in cognitive control, motivation, and reward is enhanced in obese females. Am J Clin Nutr. 2014 Aug;100(2):524-31. doi: 10.3945/ajcn.113.080671. Epub 2014 Jun 25.
Lips MA, Pijl H, van Klinken JB, de Groot GH, Janssen IM, Van Ramshorst B, Van Wagensveld BA, Swank DJ, Van Dielen F, Smit JW. Roux-en-Y gastric bypass and calorie restriction induce comparable time-dependent effects on thyroid hormone function tests in obese female subjects. Eur J Endocrinol. 2013 Aug 28;169(3):339-47. doi: 10.1530/EJE-13-0339. Print 2013 Sep.
Other Identifiers
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P08-215
Identifier Type: -
Identifier Source: org_study_id