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Trial record 33 of 405 for:    PYY

Human Intestinal Peptides Evaluation and Research (HIPER)

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ClinicalTrials.gov Identifier: NCT02532829
Recruitment Status : Unknown
Verified July 2016 by Turkish Metabolic Surgery Foundation.
Recruitment status was:  Enrolling by invitation
First Posted : August 26, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Turkish Metabolic Surgery Foundation

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.

Condition or disease Intervention/treatment
Obesity Diabetes Mellitus, Type 2 Other: blood sample analysis

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.


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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Different Metabolic States and Surgical Models on Glucose Metabolism and Secretion of Ileal L-cell Peptides
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : November 2016

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

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

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

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

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

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

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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Body Mass Index (BMI) in participants with various health conditions. [ Time Frame: Up to 6 months. ]
    BMI will be expressed in kg/m^2 (weight in kilograms and height in meters).

  2. Body Mass Index (BMI) in participants treated by different bariatric and metabolic surgical techniques. [ Time Frame: Up to 6 months. ]
    BMI will be expressed in kg/m^2 (weight in kilograms and height in meters).

  3. Waist and hip circumference in participants with various health conditions. [ Time Frame: Up to 6 months. ]
    Waist and hip circumferences will be expressed as centimeters.

  4. Waist and hip circumference in participants treated by different bariatric and metabolic surgical techniques. [ Time Frame: Up to 6 months. ]
    Waist and hip circumferences will be expressed as centimeters.

  5. Plasma glucose levels 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. Plasma glucose levels will be measured by Enzymatic Hexokinase method and results will be expressed as mg/dl.

  6. Plasma glucose levels 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. Plasma glucose levels will be measured by Enzymatic Hexokinase method and results will be expressed as mg/dl.

  7. Plasma insulin levels 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. Plasma insulin levels will be measured by ECLIA method and results will be expressed as mU/ml.

  8. Plasma insulin levels 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. Plasma insulin levels will be measured by ECLIA method and results will be expressed as mU/ml.


Other Outcome Measures:
  1. Plasma HbA1c levels in participants with various health conditions. [ Time Frame: Up to 6 months. ]
    Measurements will be performed in the fasting state using the Turbidometric Assay and results will be expressed as percentage (%).

  2. Plasma HbA1c levels in participants treated by different bariatric and metabolic surgical techniques. [ Time Frame: Up to 6 months. ]
    Measurements will be performed in the fasting state using the Turbidometric Assay and results will be expressed as percentage (%).

  3. Plasma Liver Function Tests (SGOT, SGPT and GGT levels) in participants with various health conditions. [ Time Frame: Up to 6 months. ]
    Measurements will be performed in the fasting state using IFCC Enzymatic Assay and results will be expressed as U/L.

  4. Plasma Liver Function Tests (SGOT, SGPT and GGT levels) in participants treated by different bariatric and metabolic surgical techniques. [ Time Frame: Up to 6 months. ]
    Measurements will be performed in the fasting state using IFCC Enzymatic Assay and results will be expressed as U/L.


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

For NON-SURGERY GROUPS

Inclusion Criteria:

  1. 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).

  2. Preferably not on any kind of anti-diabetic drugs or will accept cessation of all anti-diabetic drugs 2 days prior to evaluation.
  3. Absence of co-morbidities (dyslipidemia, hypertension, neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).
  4. Possibility to participate to the quadruplicate measurement protocol.

Exclusion Criteria:

  1. Anti insulin / islet antibody and glutamic acid decarboxylase antibody (antiGAD) positivity, plasma fasting C-peptide lesser than 1 ng/ml.
  2. Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
  3. Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
  4. History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
  5. Pregnancy
  6. 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

Inclusion Criteria:

  1. 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.
  2. Preferably not on any kind of anti-diabetic drugs or will accept cessation of all anti-diabetic drugs 2 days prior to evaluation.
  3. Absence of or resolved co-morbidities (dyslipidemia, hypertension, neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).
  4. Possibility to participate to the quadruplicate measurement protocol.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532829


Sponsors and Collaborators
Turkish Metabolic Surgery Foundation
Investigators
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Study Director: Alper Celik, MD Turkish Metabolic Surgery Foundation

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Turkish Metabolic Surgery Foundation
ClinicalTrials.gov Identifier: NCT02532829     History of Changes
Other Study ID Numbers: 2015/H01
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs