Human Intestinal Peptides Evaluation and Research

NCT02532829 | Unknown

• 1 other identifier: 2015/H01
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 6 months.

Secondary Outcomes (8)

• Body Mass Index (BMI) in participants with various health conditions.

  Up to 6 months.

• Body Mass Index (BMI) in participants treated by different bariatric and metabolic surgical techniques.

  Up to 6 months.

• Waist and hip circumference in participants with various health conditions.

  Up to 6 months.

• Waist and hip circumference in participants treated by different bariatric and metabolic surgical techniques.

  Up to 6 months.

• Plasma glucose levels in participants with various health conditions.

  Up to 6 months.

Other Outcomes (4)

• Plasma HbA1c levels in participants with various health conditions.

  Up to 6 months.

• Plasma HbA1c levels in participants treated by different bariatric and metabolic surgical techniques.

  Up to 6 months.

• Plasma Liver Function Tests (SGOT, SGPT and GGT levels) in participants with various health conditions.

  Up to 6 months.

Study Arms (8)

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).

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).

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).

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).

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).

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).

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).

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).

Other: blood sample analysis

Interventions

blood sample analysis OTHER

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

GROUP NS-A; GROUP NS-B; GROUP NS-C; GROUP NS-D; Group IT; Group MGB; Group SG; Group TB

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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).
• Possibility to participate to the quadruplicate measurement protocol.

You may not qualify if:

• 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.
• For SURGERY GROUPS
• 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.
• 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

Sponsors & Collaborators

• Turkish Metabolic Surgery Foundation: lead

Related Publications (12)

• 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.

  PMID: 18830747 RESULT

• 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.

  PMID: 20029383 RESULT

• 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.

  PMID: 25469034 RESULT

• 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.

  PMID: 17895322 RESULT

• 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.

  PMID: 23439632 RESULT

• 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.

  PMID: 24381724 RESULT

• 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.

  PMID: 20351741 RESULT

• 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.

  PMID: 12954742 RESULT

• 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.

  PMID: 24646534 RESULT

• 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.

  PMID: 25027983 RESULT

• 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.

  PMID: 31773794 DERIVED

• 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.

  PMID: 26975937 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alper Celik, MD

  Turkish Metabolic Surgery Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 26, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-07