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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 01, 2014