The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients

NCT ID: NCT00986700

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-09-30

Brief Summary

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High fasting glucose is a very common problem in type 2 diabetic patients. The cause is probably glucose production by the liver, known as the "dawn phenomenon". The investigators hypothesize that a late night meal can lower the fasting glucose level by early morning insulin secretion stimulated by the food. In this study the investigators intend to test the effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.

Detailed Description

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Conditions

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Fasting Hyperglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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different types of bad time food

Different types of bad time food

Group Type OTHER

late night meal

Intervention Type DIETARY_SUPPLEMENT

Three different kinds of late night meal each for 2 days.

Interventions

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late night meal

Three different kinds of late night meal each for 2 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus with HbA1c 6.5-9%, fasting glucose of 126-200 mg/dl and BMI of 27-40.

Exclusion Criteria

* Patient treated with insulin, GLP-1 analog or weight reduction medications.
* Type 1 diabetes
* Pregnancy
* Renal failure (creatinin \>1.4 for male and 1.3 for female
* Uncontrolled hypertension (\>160/100)
* Abnormal thyroid function test
* Patient treated with steroids or psychiatric medications.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Jacob Ilany MD

Senior Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SHEBA-09-7156-JI-CTIL

Identifier Type: -

Identifier Source: org_study_id

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