Clinical trial NCT04057261: Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Official title: Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Cardiovascular Diseases
Keywords: Liraglutide
Type 2 Diabetes
High Cardiovascular Risk
Myocardial Infarction
Metabolic Profile
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2019-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, prospective, placebo-controlled, double-blind, randomized, 2 arm parallel, interventional, exploratory pilot study
Primary purpose: OTHER

Brief summary: In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving the way for future research to explain the effects of Liraglutide on cardiovascular mortality and overall mortality in treated patients.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Serum levels of HbA1c ≥ 7,0%
3. Age ≥ 18 years
4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)
5. Written informed consent prior to study participation

Exclusion Criteria:

1. Type 1 diabetes
2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within the last 4 weeks
3. Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
4. Renal impairment (eGFR \< 30 mL/min)
5. Occurrence of acute vascular events within 6 weeks before screening and randomization
6. Known or suspected hypersensitivity to Liraglutide
7. Pregnant females as determined by positive (serum or urine) hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
8. Lactating females
9. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
10. The subject received an investigational drug within 30 days prior to inclusion into this study.
11. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
12. The subject is unwilling or unable to follow the procedures outlined in the protocol.
13. The subject is mentally or legally incapacitated.

Primary outcomes:
measure: Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months
timeFrame: 3 month
Secondary outcomes:
measure: change in left ventricular diastolic function
timeFrame: 3 month
measure: change in left ventricular diastolic function
timeFrame: 3 month
measure: change in left ventricular systolic function
timeFrame: 3 month
measure: Changes in systolic and diastolic blood pressure (mmHg)
timeFrame: 3 month
measure: body weight
timeFrame: 3 month
measure: Changes in NT-proBNP serum levels (pg/ml)
timeFrame: 3 month
measure: Differences of the serum lipid profile between Liraglutide treatment group and placebo group
timeFrame: 3 month
measure: changes of serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate between Liraglutide treatment group and placebo group
timeFrame: 3 month
measure: Heart rate variability
timeFrame: 3 month
measure: Resting energy expenditure
timeFrame: 3 month
measure: Respiratory Exchange Ratio
timeFrame: 3 month
measure: Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group
timeFrame: 3 month
measure: Albumin excretion
timeFrame: 3 month
measure: changes in inflammasome analyses
timeFrame: 3 month
measure: Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group
timeFrame: 3 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Internal Medicine I, University Hospital
Study officials:
References: