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Pre-meal Protein Drink Improve Glycemic Regulation (PMB/T2D)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Pre-meal protein drink
Water drink
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lindsdals hälsocentral

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pre-meal protein drink

Water drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c
Glycated hemoglobin

Secondary Outcome Measures

Postprandial glycemia
Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.

Full Information

First Posted
November 12, 2013
Last Updated
May 11, 2016
Sponsor
Lund University
Collaborators
Landstinget i Kalmar Län
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1. Study Identification

Unique Protocol Identification Number
NCT01987674
Brief Title
Pre-meal Protein Drink Improve Glycemic Regulation
Acronym
PMB/T2D
Official Title
Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Test products expired.
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Landstinget i Kalmar Län

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-meal protein drink
Arm Type
Experimental
Arm Description
A dose of 100 ml is taken just before breakfast, lunch and dinner.
Arm Title
Water drink
Arm Type
Placebo Comparator
Arm Description
A dose of 100 ml is taken just before breakfast, lunch and dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pre-meal protein drink
Intervention Type
Other
Intervention Name(s)
Water drink
Primary Outcome Measure Information:
Title
HbA1c
Description
Glycated hemoglobin
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Postprandial glycemia
Description
Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Description
HOMA-IR is a mathematical modelling of insulin resistance using fasting values of blood glucose and serum insulin.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lindsdals hälsocentral
City
Kalmar
ZIP/Postal Code
39365
Country
Sweden

12. IPD Sharing Statement

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