Metabolic Effects of Honey in Type 1 Diabetes Mellitus
This study has been completed.
Sponsor:
Ain Shams University
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
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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
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 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013