ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01680926
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
Almased Wellness GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Almased Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. insulin demand per day [ Time Frame: 12 weeks ]
    daily insulin dosage


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    HbA1c

  2. body weight [ Time Frame: 12 weeks ]
    body weight



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Stephan Martin, 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