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Acute Effect of Exenatide on Brain Glucose Metabolism

Primary Purpose

Impaired Glucose Tolerance (IGT), Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exenatide

Placebo

About this trial

This is an interventional basic science trial for Impaired Glucose Tolerance (IGT) focused on measuring Impaired glucose tolerance (IGT), Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males age 18-65 years old
Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
Patients must have BMI of 25-40 kg/m2
Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
Patients must have the following laboratory values:
- Hematocrit ≥ 34 vol%
- Serum creatinine* ≤ 1.5 mg/dl in males and
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
- Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal
- If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min

Exclusion Criteria:

Patients are excluded from participation in the study if they meet any of the following criteria:

Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
Patients with BMI over 40 and under 25
Patient with age below 18 yrs and over 65 yrs
Female subjects
Patients with type 1 diabetes
Patients treated for type 2 diabetes
Subjects with normal glucose tolerance (NGT)

Sites / Locations

Texas Diabetes Institute and UTHSCSA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exenatide first, then Placebo

Placebo first, then Exenatide

Arm Description

Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.

Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .

Outcomes

Primary Outcome Measures

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.

Secondary Outcome Measures

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.

Full Information

NCT ID

NCT01588418

First Posted

March 19, 2012

Last Updated

October 19, 2017

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Amylin Pharmaceuticals, LLC.

1. Study Identification

Unique Protocol Identification Number

NCT01588418

Brief Title

Acute Effect of Exenatide on Brain Glucose Metabolism

Official Title

Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Amylin Pharmaceuticals, LLC.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

Detailed Description

This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance (IGT), Diabetes

Keywords

Impaired glucose tolerance (IGT), Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exenatide first, then Placebo

Arm Type

Experimental

Arm Description

Arm Title

Placebo first, then Exenatide

Arm Type

Experimental

Arm Description

Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

Byetta

Intervention Description

Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was administered in random order 30 min before OGTT-PET study in the same subject

Primary Outcome Measure Information:

Title

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

Description

Time Frame

120 minutes after exenatide or placebo injection

Secondary Outcome Measure Information:

Title

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

Description

we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.

Time Frame

60 minutes after exenatide or placebo injection

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males age 18-65 years old Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes. Patients must have BMI of 25-40 kg/m2 Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included. Patients must have the following laboratory values: Hematocrit ≥ 34 vol% Serum creatinine* ≤ 1.5 mg/dl in males and Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal Alkaline phosphatase ≤ 2.5 times upper limit of normal If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min Exclusion Criteria: Patients are excluded from participation in the study if they meet any of the following criteria: Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease) Patients with BMI over 40 and under 25 Patient with age below 18 yrs and over 65 yrs Female subjects Patients with type 1 diabetes Patients treated for type 2 diabetes Subjects with normal glucose tolerance (NGT)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amalia Gastaldelli, PhD

Organizational Affiliation

UTHSCSA, San Antonio, TX

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Diabetes Institute and UTHSCSA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26116695

Citation

Daniele G, Iozzo P, Molina-Carrion M, Lancaster J, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Gastaldelli A. Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System. Diabetes. 2015 Oct;64(10):3406-12. doi: 10.2337/db14-1718. Epub 2015 Jun 26.

Results Reference

result

PubMed Identifier

27639082

Citation

Gastaldelli A, Gaggini M, Daniele G, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Iozzo P. Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study. Hepatology. 2016 Dec;64(6):2028-2037. doi: 10.1002/hep.28827.

Results Reference

result

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Acute Effect of Exenatide on Brain Glucose Metabolism

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