Clinical trial of the effect of chromium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=30) or placebo (n=30).
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=35) or placebo (n=35).
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=3035) or placebo (n=3035).
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل یاری کروم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل یاری کروم (35=n) یا پلاسبو (35=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل یاری کروم (3035=n) یا پلاسبو (3035=n) اختصاص داده خواهند شد.
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. At the beginning and the end of the intervention: 12 weeks.
Among patients with CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 70 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. At the beginning and the end of the intervention: 12 weeks.
Among patients with CHD referred to NaghaviCardiology Clinic affiliated to Kashan University of Medical Sciences, 6070 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. At the beginning and the end of the intervention: 12 weeks.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک نقویقلب وابسته به دانشگاه علوم پزشکی کاشان، 6070 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study.
Inclusion criteria: Individuals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study.
Inclusion criteria: Individuals aged 4540-85 years diagnosed with type 2 diabetes and CHD will be included in this study.
معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیار ورود به مطالعه: افراد 85-40 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیار ورود به مطالعه: افراد 85-4540 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
Exclusion criteria: Unwillingness to cooperate.
Exclusion criteria: consuming chromium three months prior to the intervention, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, change in type and dosage of antidiabetic and antilipidemic agents, having an acute myocardial infarction, a cardiac surgery in the past three months, renal or hepatic failure.
Exclusion criteria: Unwillingnessconsuming chromium three months prior to cooperatethe intervention, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, change in type and dosage of antidiabetic and antilipidemic agents, having an acute myocardial infarction, a cardiac surgery in the past three months, renal or hepatic failure.
معیار خروج از مطالعه: عدم تمایل به همکاری.
معیارهای عدم ورود: مصرف کروم سه ماه قبل از مداخله،گرفتن آنتی اکسیدانت و/یا مکمل های ضد التهابی از قبیل ویتامین E، C و اسیدهای چرب امگا-3، تغییر در نوع و دوز داروهای آنتی دیابتیک و آنتی لیپیدمیک، داشتن سکته قلبی حاد، جراحی قلب در سه ماه گذشته، اختلال کلیوی و کبدی.
معیار خروجمعیارهای عدم ورود: مصرف کروم سه ماه قبل از مطالعه: عدم تمایل به همکاریمداخله،گرفتن آنتی اکسیدانت و/یا مکمل های ضد التهابی از قبیل ویتامین E، C و اسیدهای چرب امگا-3، تغییر در نوع و دوز داروهای آنتی دیابتیک و آنتی لیپیدمیک، داشتن سکته قلبی حاد، جراحی قلب در سه ماه گذشته، اختلال کلیوی و کبدی.
General information
45
40
4540
2
3
23
60
70
6070
2018-01-10, 1396/10/20
2018-01-16, 1396/10/26
2018-01-1016 00:00:00
Inclusion Criteria: Subjects aged 45-85 years; diagnosed with type 2 diabetes and coronary heart disease.
Inclusion Criteria: Subjects aged 40-85 years; diagnosed with type 2 diabetes and coronary heart disease.
Inclusion Criteria: Subjects aged 4540-85 years; diagnosed with type 2 diabetes and coronary heart disease.
معیارهای ورود مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیارهای ورود مطالعه: افراد 85-40 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیارهای ورود مطالعه: افراد 85-4540 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
Exclusion Criteria: Unwillingness to cooperate.
Exclusion Criteria: Consuming chromium three months prior to the intervention
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Change in type and dosage of antidiabetic and antilipidemic agents
Having an acute myocardial infarction, a cardiac surgery in the past three months
Renal or hepatic failure
Exclusion Criteria: UnwillingnessConsuming chromium three months prior to cooperate.the intervention Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids Change in type and dosage of antidiabetic and antilipidemic agents Having an acute myocardial infarction, a cardiac surgery in the past three months Renal or hepatic failure
معیارهای عدم ورود: عدم تمایل به همکاری.
معیارهای عدم ورود: مصرف کروم سه ماه قبل از مداخله
گرفتن آنتی اکسیدانت و/یا مکمل های ضد التهابی از قبیل ویتامین E، C و اسیدهای چرب امگا-3
تغییر در نوع و دوز داروهای آنتی دیابتیک و آنتی لیپیدمیک
داشتن سکته قلبی حاد، جراحی قلب در سه ماه گذشته
اختلال کلیوی و کبدی
معیارهای عدم ورود: عدم تمایل به همکاری.مصرف کروم سه ماه قبل از مداخله گرفتن آنتی اکسیدانت و/یا مکمل های ضد التهابی از قبیل ویتامین E، C و اسیدهای چرب امگا-3 تغییر در نوع و دوز داروهای آنتی دیابتیک و آنتی لیپیدمیک داشتن سکته قلبی حاد، جراحی قلب در سه ماه گذشته اختلال کلیوی و کبدی
At first, all participants were categorized according to age (<65 and ≥65 y) and pre-intervention BMI (25-29.9 and ≥30 kg/m2). Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
At first, after balanced block randomisation, all participants were allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
At first, after balanced block randomisation, all participants were categorized according to age (<65 and ≥65 y) and pre-intervention BMI (25-29.9 and ≥30 kg/m2). Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس سن (<65 و ≥65) و مقادیر پایه نمایه توده بدنی (29.9-25 و ≥25 کیلوگرم بر متر مربع)، بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از تصادفی سازی بلوکی بالانس شده، بیماران برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس سن (<65 و ≥65) و مقادیر پایه نمایه توده بدنی (29.9-25 و ≥25 کیلوگرم بر متر مربع)تصادفی سازی بلوکی بالانس شده، بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi Cardiology Clinic
Name of recruitment center - Persian: کلینیک قلب نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi Cardiology Clinic Name of recruitment center - Persian: کلینیک قلب نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_z@kaums.ac.ir Web page address:
Sharing plan
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of chromium supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=35) or placebo (n=35).
Settings and conduct
Among patients with CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 70 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. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study.
Intervention groups
Exclusion criteria: consuming chromium three months prior to the intervention, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, change in type and dosage of antidiabetic and antilipidemic agents, having an acute myocardial infarction, a cardiac surgery in the past three months, renal or hepatic failure.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N30
Registration date:2018-01-26, 1396/11/06
Registration timing:retrospective
Last update:2019-09-16, 1398/06/25
Update count:1
Registration date
2018-01-26, 1396/11/06
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
2017-12-26, 1396/10/05
Expected recruitment end date
2018-01-16, 1396/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of chromium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Effect of chromium supplementation in treatment of coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: Subjects aged 40-85 years; diagnosed with type 2 diabetes and coronary heart disease.
Exclusion criteria:
Exclusion Criteria: Consuming chromium three months prior to the intervention
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Change in type and dosage of antidiabetic and antilipidemic agents
Having an acute myocardial infarction, a cardiac surgery in the past three months
Renal or hepatic failure
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
At first, after balanced block randomisation, all participants were allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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
2017-12-25, 1396/10/04
Ethics committee reference number
IR.KAUMS.REC.1396.89
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
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
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
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
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
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Chromium supplements (21st Century, Arizona, USA), 200 µg, daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran) daily for 12 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Cardiology Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available