Pre-meal Protein Drink Improve Glycemic Regulation

NCT ID: NCT01987674

Last Updated: 2016-05-12

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

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pre-meal protein drink

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Group Type EXPERIMENTAL

Pre-meal protein drink

Intervention Type DIETARY_SUPPLEMENT

Water drink

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Group Type PLACEBO_COMPARATOR

Water drink

Intervention Type OTHER

Interventions

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Pre-meal protein drink

Intervention Type DIETARY_SUPPLEMENT

Water drink

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
* age between 30-80 years
* non well controlled diabetes with HbA1c-levels above 62 mmol/mol

Exclusion Criteria

* pregnant or risk of becoming pregnant
* severe disease
* psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
* liver disease
* kidney malfunction (GFR \<60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landstinget i Kalmar Län

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Elin Östman

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lindsdals hälsocentral

Kalmar, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr2013/239-31PMB

Identifier Type: -

Identifier Source: org_study_id

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