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The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes (HYPOTESIS)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
acipimox
Placebo Oral Capsule
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Type 2 Diabetes
  • HbA1C >6%

Exclusion Criteria:

  • Insulin therapy (except: BOT=basal supported oral therapy)
  • Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery
  • Known intolerance against niacins
  • Known contra-indications against magnetic resonance (MR-) examinations

Sites / Locations

  • Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acipimox+

Placebo

Arm Description

250 mg at 0 and 180 minutes (one day)

1 Tablet at 0 and 180 minutes (one day)

Outcomes

Primary Outcome Measures

MYCL
Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo

Secondary Outcome Measures

Ejection Fraction
Left ventricular ejection fraction before and after administration of acipimox or placebo

Full Information

First Posted
October 26, 2013
Last Updated
February 16, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01980524
Brief Title
The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes
Acronym
HYPOTESIS
Official Title
HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation. Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acipimox+
Arm Type
Experimental
Arm Description
250 mg at 0 and 180 minutes (one day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 Tablet at 0 and 180 minutes (one day)
Intervention Type
Drug
Intervention Name(s)
acipimox
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Primary Outcome Measure Information:
Title
MYCL
Description
Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Ejection Fraction
Description
Left ventricular ejection fraction before and after administration of acipimox or placebo
Time Frame
180 minutes
Other Pre-specified Outcome Measures:
Title
Stroke Volume
Description
Stroke volume before and after administration of acipimox or placebo
Time Frame
180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes HbA1C >6% Exclusion Criteria: Insulin therapy (except: BOT=basal supported oral therapy) Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery Known intolerance against niacins Known contra-indications against magnetic resonance (MR-) examinations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Krebs, Prof.MD
Organizational Affiliation
Medical University of Vienna, Dept. of Internal Medicine III, Division of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes

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