Objective: The aim of this study is to determine the effects of alpha-lipoic acid supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive alpha-lipoic acid supplements (n=30) or placebo (n=30).
Settings and conduct
Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Intervention period: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 45-85 years diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Patients with thyroid disorders, Severe renal insufficiency, hepatic failure, Those experiencing an acute myocardial infarction within the past 3 months, Patients undergoing cardiac surgery within the past 3 months.
Intervention groups
Intervention group: Alpha-lipoic acid supplements (Support Nutrition Pharmaceutical Company, USA), 600 mg, daily, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) daily for 12 weeks orally
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles and inflammatory markers (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N48
Registration date:2019-02-05, 1397/11/16
Registration timing:registered_while_recruiting
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-22, 1397/11/02
Expected recruitment end date
2019-02-21, 1397/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of alpha-lipoic acid supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Alpha-lipoic acid effects on coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 45-85 years
People diagnosed with type 2 diabetes and coronary heart disease.
Exclusion criteria:
Patients with thyroid disorders.
Severe renal insufficiency
hepatic failure
Those experiencing an acute myocardial infarction within the past 3 months
Patients undergoing cardiac surgery within the past 3 months
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups.
https://stattrek.com/statistics/random-number-generator.aspx
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.102
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using homeostasis model of assessment insulin resistance formula
2
Description
Fasting serum Insulin levels
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
High-density lipoprotein (HDL) cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
high-sensitivity C-reactive protein (hs-CRP)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention