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Metabolic Effects of Honey in Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01554566
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
serum lipids [ Time Frame: 12 wk ]
Fasting serum lipids (cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol) were measured at base line, cross over (12 wk) and end point of the study (24 wk)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
C-peptide [ Time Frame: 12 week ]
Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Effects of Honey in Type 1 Diabetes Mellitus
Official Title  ICMJE Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study
Brief Summary This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks intervention periods) was used to measure honey effects. The subjects were randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Dietary Supplement: honey
The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).
Other Name: bee honey
Study Arms  ICMJE Experimental: honey, no honey
Intervention: Dietary Supplement: honey
Publications * Abdulrhman MM, El-Hefnawy MH, Aly RH, Shatla RH, Mamdouh RM, Mahmoud DM, Mohamed WS. Metabolic effects of honey in type 1 diabetes mellitus: a randomized crossover pilot study. J Med Food. 2013 Jan;16(1):66-72. doi: 10.1089/jmf.2012.0108. Epub 2012 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2012)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients with type 1 diabetes mellitus with their last HbA1C less than 10% were candidates for this study.

Exclusion Criteria:

  • Coexisting renal or hepatic impairment
  • Coexisting diseases e.g., malignancy, other endocrine disorders
  • Patients on steroid therapy or other drugs that may affect the body weight or serum lipids.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554566
Other Study ID Numbers  ICMJE honey1010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party mamdouh abdulmaksoud abdulrhman, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mamdouh AM Abdulrhman, professor pediatric department, faculty of medicine, ain shams university
Principal Investigator: Mohamed H El Hefnawy, professor national institute of diabetes and endocrinology, cairo, egypt
Principal Investigator: Rasha H Aly, assist. prof pediatric department, faculty of medicine, ain shams university
Principal Investigator: Rania H Shatla, lecturer pediatric department, faculty of medicine, ain shams university
Principal Investigator: Doaa M Mohamed, M.B.B.Ch pediatric department, faculty of medicine, ain shams university
Principal Investigator: Waheed S Mohamed, M.B.B.Ch pediatric department, faculty of medicine, ain shams university
PRS Account Ain Shams University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP