Metabolic Activation With Almased for Type 2 Diabetes Patients
Almased100
Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day
1 other identifier
interventional
22
1 country
1
Brief Summary
Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (\> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 type-2-diabetes-mellitus
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedSeptember 11, 2012
September 1, 2012
1.6 years
September 4, 2012
September 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin demand per day
daily insulin dosage
12 weeks
Secondary Outcomes (2)
HbA1c
12 weeks
body weight
12 weeks
Study Arms (1)
Almased
EXPERIMENTALDuring the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
Interventions
During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
Eligibility Criteria
You may qualify if:
- patients with type 2 diabetes
- BMI \> 27 kg/m2
- age 35-75 years
- insulin therapy \>100 U insulin per day
You may not qualify if:
- contraindication for a calorie reduced diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West German Center of Diabetes and Healthlead
- Almased Wellness GmbHcollaborator
Study Sites (1)
West German Center of Diabetes and Health
Düsseldorf, 40591, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stepahn Martin, MD
West German Center of Diabetes and Health
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
July 1, 2009
Primary Completion
February 1, 2011
Study Completion
October 1, 2011
Last Updated
September 11, 2012
Record last verified: 2012-09