The purpose of this study is to investigate the effect of nettle extract supplementation on blood sugar and AMPK enzyme level in type 2 diabetic patients in a single-blind clinical trial design. 60 male and female diabetic patients divided into two 30 groups.
Inclusion criteria: Fasting blood sugar between110- 200 mg/dl; Taking usual diabetes medicines that donot have effect on AMPK enzyme level like metformin and thiazolidinediones.
Exclusion criteria:Illness background kidney; cardiovascular; liver.
Taking usual diabetes medicines that have effect on AMPK enzyame level like metformin and thiazolidinediones; Pregnancy and Lactating; insulin injection; Smoking and use of alcohol; change in diet and exercise.
Intervention group (Taking usual diabetes medicines that donot have effect on AMPK level) ingest 20mg/kg of nettle extract 3 time a day and control group that ingest placebo in same way. Patients ingest extract and placebo for 8 weeks. Befor and after the study, the blood glucose، HbA1c، AMPK enzyame level and insulin evels in the drug group and the placebo group will be determined by laboratory methods in the first and the end of study. Results will be analyzed by SPSS software.
General information
Acronym
- - -
IRCT registration information
IRCT registration number:IRCT2014100119364N1
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Bahare Korani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 2033
Email address
h.parsian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Babol University of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-11-23, 1394/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect ofHydroalcholic aerial parts of Utrica dioica extract on Glucose level and AMPK enzyme in type 2 diabetic patients
Public title
The effect of Utrica dioica extract on Glucose level and AMPK (Adenosine Monophosphate Activated Protein Kinase)enzyme
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Fasting blood sugar between110- 200 mg/dl; Taking usual diabetes medicines that donot have effect on AMPK enzyme level like metformin and thiazolidinediones;
Exclusion criteria:Illness background kidney; cardiovascular; liver.
Taking usual diabetes medicines that have effect on AMPK enzyame level like metformin and thiazolidinediones; Pregnancy and Lactating; insulin injection; Smoking and use of alcohol; change in diet and exercise.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
---
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Postal code
41367
Approval date
2014-12-10, 1393/09/19
Ethics committee reference number
304930
Health conditions studied
1
Description of health condition studied
type 2 diabet
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus type 2
Primary outcomes
1
Description
AMPK (Adenosine Monophosphate Activated Protein Kinaseenzme level
Timepoint
Befor & after intervention
Method of measurement
Immune assay
2
Description
Glucose blood level
Timepoint
befor & after intervention
Method of measurement
spectrophotometric assay(kit)
Secondary outcomes
1
Description
Hb A1C
Timepoint
Before & after intervention
Method of measurement
Spectrophotometric assay (kit)
2
Description
Insulin
Timepoint
Before & after intervention
Method of measurement
Immune assay
Intervention groups
1
Description
Intervention:drug (HydroAlcholic Utrica dioica Extract)
Intervention group (Taking usual diabetes medicines that donot have effect on AMPK level) ingest 20mg/kg of nettle extract 3 time a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control:placebo
Control group(Taking usual diabetes medicines that donot have effect on AMPK level) ingest 20mg/kg of placebo 3 times a day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Dr. Ali Mirzapour
Street address
Rohani Hospital, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Moghadamnia
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Babol University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Giah Essence Phytopharm co.
Full name of responsible person
Dr. Mohammad Hadi Soleimani
Street address
Dr. Soleimani pharmacy,5 Azar Blvd, Gorgan, Golestan.
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Giah Essence Phytopharm co.
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Bahare Korani
Position
M.Sc student of clinical biochemistry
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Postal code
Phone
+98 83 3432 8876
Fax
Email
bahar_korani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Hadi Parsian
Position
Ph.D of Clinical Biochemistry
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Postal code
41367
Phone
+98 112192033
Fax
-
Email
hadiparsian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Bahare Korani
Position
M.Sc student of clinical biochemistry
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Postal code
-
Phone
+98 83 3432 8876
Fax
-
Email
bahar_korani@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)