ObesityHIPERNCT02532829

Human Intestinal Peptides Evaluation and Research

An observational study of Obesity and Diabetes Mellitus, Type 2, run by Turkish Metabolic Surgery Foundation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Diabetes Mellitus, Type 2
What is being tested?: blood sample analysis
Type of treatment: Pill or oral medicine
How many people: 240 participants
Where: No sites listed yet
Study dates: Sep 2015to Nov 2016
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 30 to 60 years
All sexes
Healthy volunteers accepted
Adult

Study population: 1. GROUP NS-A: Healthy participants, no known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2. 2. GROUP NS-B: Obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2. 3. GROUP NS-C: Non-obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2. 4. GROUP NS-D: Obese non-diabetics, HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2. 5. Group SG: Participants who underwent sleeve gastrectomy 6. Group MGB: Participants who underwent mini-gastric bypass 7. Group IT: Participants who underwent sleeve gastrectomy with ileal transposition 8. Group TB: Participants who underwent sleeve gastrectomy with transit bipartition

Who may be able to join

GROUP NS-A: Healthy participants, no known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2 (n=30).
GROUP NS-B: Obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2 (n=30).
GROUP NS-C: Non-obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2 (n=30).
GROUP NS-D: Obese non-diabetics, HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2 (n=30).
Preferably not on any kind of anti-diabetic drugs or will accept cessation of all anti-diabetic drugs 2 days prior to evaluation.
Absence of co-morbidities (dyslipidemia, hypertension, neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).

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Possibility to participate to the quadruplicate measurement protocol.
Type 2 Diabetic participants who underwent a sleeve gastrectomy, a mini-gastric bypass, a sleeve gastrectomy with ileal transposition or a sleeve gastrectomy with transit bipartition performed more than 6 months ago, but within the last 2 years, with steady weight profile.
Preferably not on any kind of anti-diabetic drugs or will accept cessation of all anti-diabetic drugs 2 days prior to evaluation.
Absence of or resolved co-morbidities (dyslipidemia, hypertension, neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).
Possibility to participate to the quadruplicate measurement protocol.

Who cannot join

Anti insulin / islet antibody and glutamic acid decarboxylase antibody (antiGAD) positivity, plasma fasting C-peptide lesser than 1 ng/ml.
Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
Pregnancy
Any conditions that at the discretion of the head of the study can represent risk to the participant or could affect the protocol results.

Show all 12Show fewer

For SURGERY GROUPS
Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
Pregnancy
Any conditions that at the discretion of the head of the study can represent risk to the participant or could affect the protocol results.

About this study

Official title: Effects of Different Metabolic States and Surgical Models on Glucose Metabolism and Secretion of Ileal L-cell Peptides

The HIPER-1 study is a single centre cross sectional study in which a total of 240 participants (in different metabolic states and surgical models) will receive an Oral Mixed Meal Tolerance Test (OMTT). At baseline and after 30, 60 and 120 minutes the PYY levels, GLP-1 levels, glucose and insulin sensitivity will be measured. The primary endpoint of the study will be the area under the GLP-1 and Peptide - YY curves and insulin sensitivity following the OMTT.

Read the detailed description

Obesity and type 2 diabetes mellitus (T2DM) are increasing worldwide, thus reaching pandemic proportions. Diet, exercise and medication remain the cornerstones of type 2 diabetes mellitus treatment. But, apart from studies demonstrating promising results in some of the developed countries; the long-term success rates of lifestyle and drug modifications are disappointing. In cases where classic strategies proved to be inadequate, broad type of gastrointestinal (GI) surgery methods offer new alternatives to treat obesity and T2DM. The variable levels of incretin stimulation (especially GLP-1) and improved glycaemic control in those with diabetes have been shown following various bariatric techniques.

Therefore, investigators aimed to analyze the levels of GLP-1 and Peptide YY hormones together with indices of insulin sensitivity in participants with various health conditions and in participants who underwent different surgical options including sleeve gastrectomy, minigastric bypass, sleeve gastrectomy with ileal transposition and sleeve gastrectomy with transit bipartition.

Conditions: Obesity, Diabetes Mellitus, Type 2
Being tested: blood sample analysis
Medical subject headings: Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

blood sample analysisOther
Measurement of GLP-1, Peptide YY, Glucose and Insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test.

Study groups in NCT02532829
Study group	Role	What they receive
GROUP NS-A		Healthy Participants: No known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
GROUP NS-B		Obese, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
GROUP NS-C		Non-obese, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
GROUP NS-D		Obese non-diabetic: HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
Group SG		Type 2 Diabetic participants who underwent a sleeve gastrectomy, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
Group MGB		Type 2 Diabetic participants who underwent a mini-gastric bypass, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
Group IT		Type 2 Diabetic participants who underwent a sleeve gastrectomy with ileal transposition, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis
Group TB		Type 2 Diabetic participants who underwent a sleeve gastrectomy with transit bipartition, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test). Receives: Other: blood sample analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma GLP-1 and P-YY measurements by ELISA in participants with various health conditions.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test and results will be expressed as pmol/L.
Measured: Up to 6 months.
Plasma GLP-1 and P-YY measurements by ELISA in participants treated by different bariatric and metabolic surgical techniques.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test and results will be expressed as pmol/L.
Measured: Up to 6 months.

Secondary outcomes (8)

Body Mass Index (BMI) in participants with various health conditions.
BMI will be expressed in kg/m^2 (weight in kilograms and height in meters).
Measured: Up to 6 months.
Body Mass Index (BMI) in participants treated by different bariatric and metabolic surgical techniques.
BMI will be expressed in kg/m^2 (weight in kilograms and height in meters).
Measured: Up to 6 months.
Waist and hip circumference in participants with various health conditions.
Waist and hip circumferences will be expressed as centimeters.
Measured: Up to 6 months.
Waist and hip circumference in participants treated by different bariatric and metabolic surgical techniques.
Waist and hip circumferences will be expressed as centimeters.
Measured: Up to 6 months.
Plasma glucose levels in participants with various health conditions.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test. Plasma glucose levels will be measured by Enzymatic Hexokinase method and results will be expressed as mg/dl.
Measured: Up to 6 months.
Plasma glucose levels in participants treated by different bariatric and metabolic surgical techniques.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test. Plasma glucose levels will be measured by Enzymatic Hexokinase method and results will be expressed as mg/dl.
Measured: Up to 6 months.
Plasma insulin levels in participants with various health conditions.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test. Plasma insulin levels will be measured by ECLIA method and results will be expressed as mU/ml.
Measured: Up to 6 months.
Plasma insulin levels in participants treated by different bariatric and metabolic surgical techniques.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test. Plasma insulin levels will be measured by ECLIA method and results will be expressed as mU/ml.
Measured: Up to 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Nov 2016

First posted26 Aug 2015 (estimated)
Study startSep 2015
Primary completionJul 2016
Study completionNov 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)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: Cohort
Time perspective: Prospective
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532829
Sponsor's protocol ID: 2015/H01
Acronym: HIPER
Status last verified: Jul 2016
First submitted: 13 Aug 2015
Last updated: 25 Oct 2016
Results posted: No
Data monitoring committee: No

Publications

DePaula AL, Macedo AL, Schraibman V, Mota BR, Vencio S. Hormonal evaluation following laparoscopic treatment of type 2 diabetes mellitus patients with BMI 20-34. Surg Endosc. 2009 Aug;23(8):1724-32. doi: 10.1007/s00464-008-0168-6. Epub 2008 Oct 2.
PubMed 18830747
Kashyap SR, Daud S, Kelly KR, Gastaldelli A, Win H, Brethauer S, Kirwan JP, Schauer PR. Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes. Int J Obes (Lond). 2010 Mar;34(3):462-71. doi: 10.1038/ijo.2009.254. Epub 2009 Dec 22.
PubMed 20029383
Finelli C, Padula MC, Martelli G, Tarantino G. Could the improvement of obesity-related co-morbidities depend on modified gut hormones secretion? World J Gastroenterol. 2014 Nov 28;20(44):16649-64. doi: 10.3748/wjg.v20.i44.16649.
PubMed 25469034
Goldfine AB, Mun EC, Devine E, Bernier R, Baz-Hecht M, Jones DB, Schneider BE, Holst JJ, Patti ME. Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal. J Clin Endocrinol Metab. 2007 Dec;92(12):4678-85. doi: 10.1210/jc.2007-0918. Epub 2007 Sep 25.
PubMed 17895322
Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.
PubMed 23439632
Troke RC, Tan TM, Bloom SR. The future role of gut hormones in the treatment of obesity. Ther Adv Chronic Dis. 2014 Jan;5(1):4-14. doi: 10.1177/2040622313506730.
PubMed 24381724
Essah PA, Levy JR, Sistrun SN, Kelly SM, Nestler JE. Effect of weight loss by a low-fat diet and a low-carbohydrate diet on peptide YY levels. Int J Obes (Lond). 2010 Aug;34(8):1239-42. doi: 10.1038/ijo.2010.48. Epub 2010 Mar 30.
PubMed 20351741
Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.
PubMed 12954742
Santoro S. From Bariatric to Pure Metabolic Surgery: New Concepts on the Rise. Ann Surg. 2015 Aug;262(2):e79-80. doi: 10.1097/SLA.0000000000000590. No abstract available.
PubMed 24646534
Celik A, Ugale S. Functional restriction and a new balance between proximal and distal gut: the tools of the real metabolic surgery. Obes Surg. 2014 Oct;24(10):1742-3. doi: 10.1007/s11695-014-1368-x. No abstract available.
PubMed 25027983
Cagiltay E, Celik A, Dixon JB, Pouwels S, Santoro S, Gupta A, Ugale S, Abdul-Ghani M. Effects of different metabolic states and surgical models on glucose metabolism and secretion of ileal L-cell peptides: results from the HIPER-1 study. Diabet Med. 2020 Apr;37(4):697-704. doi: 10.1111/dme.14191. Epub 2019 Dec 15.
PubMed 31773794
Celik A, Dixon JB, Pouwels S, Celik BO, Karaca FC, Gupta A, Santoro S, Ugale S. Effects of different metabolic states and surgical models on glucose metabolism and secretion of ileal L-cell peptides: protocol for a cross-sectional study. BMJ Open. 2016 Mar 14;6(3):e010245. doi: 10.1136/bmjopen-2015-010245.
PubMed 26975937

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Different Metabolic States and Surgical Models on Glucose Metabolism and Secretion of Ileal L-cell Peptides
ClinicalTrials.gov ID: NCT02532829
Acronym / sponsor ID: HIPER / 2015/H01
Conditions: Obesity, Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Unknown status
Enrolment: 240 participants (estimated)
Lead sponsor: Turkish Metabolic Surgery FoundationUniversity, hospital or other
Study start: Sep 2015
Primary completion: Jul 2016 (actual)
Study completion: Nov 2016 (estimated)
First posted: 26 Aug 2015 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 8

Arm	Type	Receives
GROUP NS-A	–	Other: blood sample analysisHealthy Participants: No known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
GROUP NS-B	–	Other: blood sample analysisObese, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
GROUP NS-C	–	Other: blood sample analysisNon-obese, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
GROUP NS-D	–	Other: blood sample analysisObese non-diabetic: HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2 (n=30). Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
Group SG	–	Other: blood sample analysisType 2 Diabetic participants who underwent a sleeve gastrectomy, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
Group MGB	–	Other: blood sample analysisType 2 Diabetic participants who underwent a mini-gastric bypass, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
Group IT	–	Other: blood sample analysisType 2 Diabetic participants who underwent a sleeve gastrectomy with ileal transposition, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).
Group TB	–	Other: blood sample analysisType 2 Diabetic participants who underwent a sleeve gastrectomy with transit bipartition, performed more than 6 months ago, but within the last 2 years, with steady weight profile. Blood sample analysis (Blood samples will be taken for the analysis of GLP-1, Peptide YY, glucose and insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test).

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: 1. GROUP NS-A: Healthy participants, no known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2. 2. GROUP NS-B: Obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2. 3. GROUP NS-C: Non-obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2. 4. GROUP NS-D: Obese non-diabetics, HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2. 5. Group SG: Participants who underwent sleeve gastrectomy 6. Group MGB: Participants who underwent mini-gastric bypass 7. Group IT: Participants who underwent sleeve gastrectomy with ileal transposition 8. Group TB: Participants who underwent sleeve gastrectomy with transit bipartition

Key inclusion criteria (11 listed)

GROUP NS-A: Healthy participants, no known disease, no previous surgery, HbA1c<5.7%, BMI<25 kg/m2 (n=30).
GROUP NS-B: Obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI>30 kg/m2 (n=30).
GROUP NS-C: Non-obese diabetic, type 2 diabetes diagnosis longer than 3 years; BMI<30 kg/m2 (n=30).
GROUP NS-D: Obese non-diabetics, HbA1c<5.7%, No signs and history of T2D, and BMI>30 kg/m2 (n=30).
Preferably not on any kind of anti-diabetic drugs or will accept cessation of all anti-diabetic drugs 2 days prior to evaluation.

Key exclusion criteria (12 listed)

Anti insulin / islet antibody and glutamic acid decarboxylase antibody (antiGAD) positivity, plasma fasting C-peptide lesser than 1 ng/ml.
Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
Pregnancy

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
blood sample analysisMeasurement of GLP-1, Peptide YY, Glucose and Insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test.	Other	GROUP NS-A, GROUP NS-B, GROUP NS-C, GROUP NS-D, Group IT, Group MGB, Group SG, Group TB

Primary outcome

Plasma GLP-1 and P-YY measurements by ELISA in participants with various health conditions.
Time frame: Up to 6 months.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test and results will be expressed as pmol/L.
Plasma GLP-1 and P-YY measurements by ELISA in participants treated by different bariatric and metabolic surgical techniques.
Time frame: Up to 6 months.
Measurements will be performed before and 30-60-120 minutes after a mixed meal test and results will be expressed as pmol/L.

8 secondary outcomes

Body Mass Index (BMI) in participants with various health conditions.
Time frame: Up to 6 months.
Body Mass Index (BMI) in participants treated by different bariatric and metabolic surgical techniques.
Time frame: Up to 6 months.
Waist and hip circumference in participants with various health conditions.
Time frame: Up to 6 months.
Waist and hip circumference in participants treated by different bariatric and metabolic surgical techniques.
Time frame: Up to 6 months.
Plasma glucose levels in participants with various health conditions.
Time frame: Up to 6 months.
Plasma glucose levels in participants treated by different bariatric and metabolic surgical techniques.
Time frame: Up to 6 months.
Plasma insulin levels in participants with various health conditions.
Time frame: Up to 6 months.
Plasma insulin levels in participants treated by different bariatric and metabolic surgical techniques.
Time frame: Up to 6 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Results publication: PubMed 18830747DePaula AL, Macedo AL, Schraibman V, Mota BR, Vencio S. Hormonal evaluation following laparoscopic treatment of type 2 diabetes mellitus patients with BMI 20-34. Surg Endosc. 2009 Aug;23(8):1724-32. doi: 10.1007/s00464-008-0168-6. Epub 2008 Oct 2.
Results publication: PubMed 20029383Kashyap SR, Daud S, Kelly KR, Gastaldelli A, Win H, Brethauer S, Kirwan JP, Schauer PR. Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes. Int J Obes (Lond). 2010 Mar;34(3):462-71. doi: 10.1038/ijo.2009.254. Epub 2009 Dec 22.
Results publication: PubMed 25469034Finelli C, Padula MC, Martelli G, Tarantino G. Could the improvement of obesity-related co-morbidities depend on modified gut hormones secretion? World J Gastroenterol. 2014 Nov 28;20(44):16649-64. doi: 10.3748/wjg.v20.i44.16649.
Results publication: PubMed 17895322Goldfine AB, Mun EC, Devine E, Bernier R, Baz-Hecht M, Jones DB, Schneider BE, Holst JJ, Patti ME. Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal. J Clin Endocrinol Metab. 2007 Dec;92(12):4678-85. doi: 10.1210/jc.2007-0918. Epub 2007 Sep 25.
Results publication: PubMed 23439632Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.
Results publication: PubMed 24381724Troke RC, Tan TM, Bloom SR. The future role of gut hormones in the treatment of obesity. Ther Adv Chronic Dis. 2014 Jan;5(1):4-14. doi: 10.1177/2040622313506730.
Results publication: PubMed 20351741Essah PA, Levy JR, Sistrun SN, Kelly SM, Nestler JE. Effect of weight loss by a low-fat diet and a low-carbohydrate diet on peptide YY levels. Int J Obes (Lond). 2010 Aug;34(8):1239-42. doi: 10.1038/ijo.2010.48. Epub 2010 Mar 30.
Results publication: PubMed 12954742Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.
Results publication: PubMed 24646534Santoro S. From Bariatric to Pure Metabolic Surgery: New Concepts on the Rise. Ann Surg. 2015 Aug;262(2):e79-80. doi: 10.1097/SLA.0000000000000590. No abstract available.
Results publication: PubMed 25027983Celik A, Ugale S. Functional restriction and a new balance between proximal and distal gut: the tools of the real metabolic surgery. Obes Surg. 2014 Oct;24(10):1742-3. doi: 10.1007/s11695-014-1368-x. No abstract available.
Derived from this study: PubMed 31773794Cagiltay E, Celik A, Dixon JB, Pouwels S, Santoro S, Gupta A, Ugale S, Abdul-Ghani M. Effects of different metabolic states and surgical models on glucose metabolism and secretion of ileal L-cell peptides: results from the HIPER-1 study. Diabet Med. 2020 Apr;37(4):697-704. doi: 10.1111/dme.14191. Epub 2019 Dec 15.
Derived from this study: PubMed 26975937Celik A, Dixon JB, Pouwels S, Celik BO, Karaca FC, Gupta A, Santoro S, Ugale S. Effects of different metabolic states and surgical models on glucose metabolism and secretion of ileal L-cell peptides: protocol for a cross-sectional study. BMJ Open. 2016 Mar 14;6(3):e010245. doi: 10.1136/bmjopen-2015-010245.

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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.

Alper Celik, MD study director

Turkish Metabolic Surgery Foundation

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Diabetes Mellitus, Type 2, run by Turkish Metabolic Surgery Foundation.

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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Plasma GLP-1 and P-YY measurements by ELISA in participants with various health conditions. (time frame: Up to 6 months.). The study lists 2 primary outcomes in all. 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 NCT02532829, which also lists 12 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 25 Oct 2016.