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Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Dyslipidaemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
nicotine acid
placebo
Sponsored by
GWT-TUD GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women)
  • further components of the metabolic syndrome: Hypertension: blood pressure >= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and Obesity: waist circumferences > 102 cm in men or >88 cm in women

Exclusion Criteria:

  • Contraindication and incompatibility of nicotine acid
  • Patients with ulcus ventriculi or ulcus duodeni
  • Intake of lipid lowering drugs < 6 weeks before randomization
  • therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C>=8.0%
  • cardiovascular events in the last 6 months
  • chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
  • ALAT elevation 2.5 times more than the normal limit
  • pregnancy

Sites / Locations

  • GWT-TUD GmbH, Centre for Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication

16 weeks treatment with placebo

Outcomes

Primary Outcome Measures

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome

Secondary Outcome Measures

Full Information

First Posted
April 10, 2008
Last Updated
January 10, 2012
Sponsor
GWT-TUD GmbH
Collaborators
Technische Universität Dresden, University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT00659321
Brief Title
Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome
Official Title
Placebokontrollierte Untersuchung Zur Wirkung Von Nikotinsäure Auf Die Dyslipidämie Bei Metabolischem Syndrom Und Das Arterioskleroserisiko (Placebo Controlled Investigation of Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome and the Risk of Atherosclerosis)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GWT-TUD GmbH
Collaborators
Technische Universität Dresden, University of Regensburg

4. Oversight

5. Study Description

Brief Summary
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
16 weeks treatment with placebo
Intervention Type
Drug
Intervention Name(s)
nicotine acid
Intervention Description
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
16 weeks treatment with placebo
Primary Outcome Measure Information:
Title
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome
Time Frame
after 16 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women) further components of the metabolic syndrome: Hypertension: blood pressure >= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and Obesity: waist circumferences > 102 cm in men or >88 cm in women Exclusion Criteria: Contraindication and incompatibility of nicotine acid Patients with ulcus ventriculi or ulcus duodeni Intake of lipid lowering drugs < 6 weeks before randomization therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C>=8.0% cardiovascular events in the last 6 months chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa) ALAT elevation 2.5 times more than the normal limit pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markolf Hanefeld, MD, PhD
Organizational Affiliation
GWT-TUD GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
GWT-TUD GmbH, Centre for Clinical Studies
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

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