ObesityNCT01167959
Hypothalamic Function Before and After Bariatric Surgery
An observational study of Obesity and Diabetes, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- Roux en Y gastric bypass and lap. gastric banding and Prodimed dietary intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese (type 2 diabetic or not) population from primary care (dietary intervention) and hospital setting (bariatric surgery)
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Centre
Leiden, South Holland, 2333 ZA
About this study
Official title: 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
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.
- Being tested
- Roux en Y gastric bypass and lap. gastric banding, Prodimed dietary intervention
- Keywords
- Obesity, Diabetes, Bariatric surgery
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en Y gastric bypass and lap. gastric bandingProcedure or surgery
Standard RYGB and LAGB procedures
Prodimed dietary interventionBehavioural
3 months of using the prodimed diet
| Study group | Role | What they receive |
|---|---|---|
| obesity diabetes, surgical and dietary | Not described Receives: Procedure: Roux en Y gastric bypass and lap. gastric banding; Behavioral: Prodimed dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut hormones
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Anne Lips, Leiden University Medical Center
- Investigators
- Hanno Pijl, MD Phd Proff, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167959
- Sponsor's protocol ID
- P08-215
- Status last verified
- Dec 2012
- First submitted
- 21 Jul 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27312699Lips 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.
PubMed 25315204Lips 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.
PubMed 24965310Lips 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.
PubMed 23811187
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01167959
- Acronym / sponsor ID
- P08-215
- Keywords
- Obesity, Diabetes, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity diabetes, surgical and dietary | – | Procedure: Roux en Y gastric bypass and lap. gastric banding, Behavioral: Prodimed dietary intervention |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese (type 2 diabetic or not) population from primary care (dietary intervention) and hospital setting (bariatric surgery)
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux en Y gastric bypass and lap. gastric bandingStandard RYGB and LAGB procedures | Procedure or surgery | obesity diabetes, surgical and dietary |
| Prodimed dietary intervention3 months of using the prodimed diet | Behavioural | obesity diabetes, surgical and dietary |
Primary outcome
Changes in gut hormones
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
- Derived from this study: PubMed 27312699Maessen 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.
- Derived from this study: PubMed 25315204Lips 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.
- Derived from this study: PubMed 24965310Lips 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.
- Derived from this study: PubMed 23811187Lips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanno Pijl, MD Phd Proff principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut hormones (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01167959, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.