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Metabolic Activation With Almased for Type 2 Diabetes Patients (Almased100)

This study has been completed.
Sponsor:
Collaborator:
Almased Wellness GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01680926
First received: September 4, 2012
Last updated: September 9, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Dietary Supplement: Almased
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West German Center of Diabetes and Health:

Primary Outcome Measures:
  • insulin demand per day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    daily insulin dosage


Secondary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HbA1c

  • body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    body weight


Enrollment: 22
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Almased
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.
 Dietary Supplement: Almased
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.
Other Name: Almased-Vitalkost

Detailed Description:

The pilot study included patients with type 2 diabetes (n=22), that injected >100 U insulin daily. 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. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 diabetes
  • BMI > 27 kg/m2
  • age 35-75 years
  • insulin therapy >100 U insulin per day

Exclusion Criteria:

  • contraindication for a calorie reduced diet
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680926

Locations
Germany
West German Center of Diabetes and Health
Düsseldorf, Germany, 40591
Sponsors and Collaborators
West German Center of Diabetes and Health
Almased Wellness GmbH
Investigators
Principal Investigator: Stepahn Martin, MD West German Center of Diabetes and Health
  More Information

Additional Information:
Homepage WDGZ  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stephan Martin, Principal Investigator, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT01680926     History of Changes
Other Study ID Numbers: Almased100
Study First Received: September 4, 2012
Last Updated: September 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by West German Center of Diabetes and Health:
type 2 diabetes mellitus
insulin
hbA1c
body weight

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013