Human Intestinal Peptides Evaluation and Research (HIPER)

October 24, 2016 updated by: Turkish Metabolic Surgery Foundation

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months.
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.
Up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 6 months.
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).
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%).
Up to 6 months.
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 (%).
Up to 6 months.
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.
Up to 6 months.
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.
Up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Alper Celik, MD, Turkish Metabolic Surgery Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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