The effects of supplementation with caffeine alone and in combination with aerobic training on some insulin resistance indices in patients with type 2 diabetes: a double-blind and placebo-controlled clinical trial
Determining the effect of caffeine supplementation alone and in combination with aerobic exercise will be some of the indicators of insulin resistance in patients with type 2 diabetes.
Design
Semi-experimental clinical trials with pre-test and post-test design
Settings and conduct
Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Men with type 2 diabetes
Being in the age range of 40-60 years, fasting blood sugar between 250-125 mg per deciliter, not suffering from diabetes-related diseases (such as neuropathy, nephropathy, retinopathy), lack of regular participation in regular exercise activities more than one session per week in For the past 3 months, not having blood pressure above 140.90 mm Hg and having more than a year of history will be a sign of diabetes.
Intervention groups
training group (TR)
training and caffeine group (TR plus CA)
caffeine group (CA)
diabetic control group (C)
The effects of supplementation with caffeine alone and in combination with aerobic training on some insulin resistance indices in patients with type 2 diabetes: a double-blind and placebo-controlled clinical trial
Public title
Effects of caffeine and aerobic training on type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood sugar between 250-125 mg / dL
Lack of diabetes-related diseases (such as neuropathy, nephropathy, retinopathy)
Lack of regular participation in regular phusical activities more than one session per week during the last 3 months
No blood pressure above 140/90 mm Hg
Exclusion criteria:
Complications of diabetes such as diabetic foot
History of cardiovascular disease
Age
From 50 years old to 55 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are leading researchers, especially in trials initiated by RASA academic researchers, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for patient care, data collection authorities and those.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences Attar Neishabouri St., Tabriz, I. R. Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5384143841
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.TBZMED.REC.1398.1179
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
leptin
Timepoint
The first stage before the start of supplementation and training and the second stage 24 hours after the last training session
Method of measurement
The double-antibody sandwich ELISA
2
Description
Adiponectin
Timepoint
The first stage before the start of supplementation and training and the second stage 24 hours after the last training session
Method of measurement
ELISA
Secondary outcomes
1
Description
Glucose
Timepoint
The first stage before the start of supplementation and training and the second stage 24 hours after the last training session
Method of measurement
Glucose oxidase methods
2
Description
Insulin
Timepoint
The first stage before the start of supplementation and training and the second stage 24 hours after the last training session
Method of measurement
Competitive ELISA
3
Description
Homeostatic model assessment (HOMA)
Timepoint
The first stage before the start of supplementation and training and the second stage 24 hours after the last training session
Intervention group: The first intervention group 8 weeks of walking on the treadmill with a slope of zero degrees for 40 minutes with an intensity of 70-60% heart rate reserve for three days pervweek
Category
Prevention
2
Description
Intervention group: The second intervention group consumed 3 mg per kg body weight per day of caffeine capsules for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nutrition and Food Sciences
Full name of responsible person
Alireza ostadrahimi
Street address
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences Attar Neishabouri St., Tabriz, I. R. Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5632146527
Phone
+98 41 3335 7580
Email
Alirezaostadrahimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza ostadrahimi
Street address
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences Attar Neishabouri St., Tabriz, I. R. Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5384143841
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?