The effect of 8 weeks vitamin D supplementation and water training on serum glycosylated hemoglobin, CRP, insulin resistance and lipid profile in women with type 2 diabetes
The effects of 8 weeks vitamin D supplementation and water exercise on serum glycosylated hemoglobin, CRP, insulin resistance and lipid profile in women with type 2 diabetes
Design
The subjects participated in a briefing session one week before the implementation of the main research protocol. In this session, in addition to explaining the research steps, they signed a written consent to participate in the test. Some anthropometric indices such as height, weight, blood pressure, heart rate, and body mass index (BMI) were measured. The age and medical history of individuals were completed using a questionnaire. To evaluate the diet of the subjects in terms of vitamin D intake and ensure that the diet did not change, a 24-hour recall questionnaire was completed at the beginning and end of the study.
Subjects were then randomly divided into four groups
Settings and conduct
Each session was performed from 9 to 10 in the morning for one hour in the shallow part (80 cm) of the pool of Razi University in Kermanshah. The intensity of the exercises was controlled using Borg comparison.
Participants/Inclusion and exclusion criteria
No smoking
• No history of cardiovascular disease
• Do not have any joint disease
• No fear of water
• Older women between 40 and 60 years old
Intervention groups
4 groups include: Group 1: Exercise in water (12 people); Group 2: Exercise in water with vitamin D supplementation (12 people); Group 3: Vitamin D supplementation (n = 12); Fourth group: control (12 people) was divided.
Main outcome variables
Glycosylated hemoglobin
Reactive protein C
Insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201223049811N1
Registration date:2021-01-12, 1399/10/23
Registration timing:retrospective
Last update:2021-01-12, 1399/10/23
Update count:0
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
Mohammad Azizi
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3832 4201
Email address
mo.azizi@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2016-05-04, 1395/02/15
Actual recruitment end date
2016-07-06, 1395/04/16
Trial completion date
2019-07-07, 1398/04/16
Scientific title
The effect of 8 weeks vitamin D supplementation and water training on serum glycosylated hemoglobin, CRP, insulin resistance and lipid profile in women with type 2 diabetes
Public title
The effect of water exercise and vitamin D consumption on the health of diabetics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes
non-athlete
40-60 years old
women
Exclusion criteria:
Being a smoker
Having heart disease
Fracture or joint injury
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
48
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table, all subjects were divided into 4 equal groups. And were randomly assigned to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the groups and researchers were aware of the status of supplementation and training, and an individual in charge of holding training sessions has taken responsibility for this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
The end of the passport street - Nik Farjaman Comple
City
kermanshah
Province
Kermanshah
Postal code
3257970692
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.KUMS.REC.1397.656
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
At the beginning of the study and after 8 weeks
Method of measurement
In the blood and by chromatographic method with ion exchange and using Pars kit test was measured.
Secondary outcomes
1
Description
Reactive protein C
Timepoint
At the beginning of the study and after 8 weeks
Method of measurement
In Blood and using ELISA method and kit (ADMA-ELISA, DLD Diagnostika GmbH, Hamburg, Germany) were measured using GC-MS method.
Intervention groups
1
Description
Intervention group: Water exercise group: Do your exercises in water for 8 weeks and every week for three sessions (24 sessions in total) and each session from 9 to 10 in the morning for one hour in the shallow part (120-80 cm) ) Razi University swimming pool in Kermanshah.
Category
Prevention
2
Description
Intervention group: Exercise and vitamin D supplementation: Exactly the same as the exercise group in water, they exercised in water for 8 weeks and also received vitamin D1 perl supplement 1 per week for 8 weeks.
Category
Prevention
3
Description
Intervention group: Vitamin D intake: For 8 weeks and once a week, they received a vitamin D supplement of 1 Perl IU50000.
Category
Prevention
4
Description
Control group: did not have any indoor or outdoor exercise for 8 weeks. They also did not take any supplements.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Mona Salari nia
Street address
2th simetri, Nobahar street
City
kermanshah
Province
Kermanshah
Postal code
3257970692
Phone
+98 83 3832 4201
Email
mona.salarinia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hadi Khalvandi
Street address
2th simetri, Nobahar street
City
Kermanshah
Province
Kermanshah
Postal code
3257970692
Phone
+98 83 3832 4201
Email
hadikhalvandi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?