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Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

honey

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring honey, diabetes, lipids, c-peptide

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Diabetes and Endocrinology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

honey, no honey

Arm Description

Outcomes

Primary Outcome Measures

serum lipids

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

Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)

Full Information

NCT ID

NCT01554566

First Posted

March 9, 2012

Last Updated

March 14, 2012

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT01554566

Brief Title

Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Official Title

Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

honey, diabetes, lipids, c-peptide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

honey, no honey

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

honey

Other Intervention Name(s)

bee honey

Intervention Description

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).

Primary Outcome Measure Information:

Title

serum lipids

Description

Time Frame

12 wk

Secondary Outcome Measure Information:

Title

C-peptide

Description

Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)

Time Frame

12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: