Metabolic Effects of Honey in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01554566
First received: March 9, 2012
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Type 1 Diabetes Mellitus
Dietary Supplement: honey
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • serum lipids [ Time Frame: 12 wk ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • C-peptide [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)


Enrollment: 20
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: honey, no honey 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

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554566

Locations
Egypt
National Institute of Diabetes and Endocrinology
Cairo, Kasr El Ainy, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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
  More Information

Additional Information:
No publications provided by Ain Shams University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mamdouh abdulmaksoud abdulrhman, Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT01554566     History of Changes
Other Study ID Numbers: honey1010
Study First Received: March 9, 2012
Last Updated: March 14, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Ain Shams University:
honey
diabetes
lipids
c-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014