Status:
COMPLETED
Metabolic Activation With Protein-rich Formula Diet
Lead Sponsor:
West German Center of Diabetes and Health
Collaborating Sponsors:
Almased Wellness GmbH
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-79 years
Phase:
NA
Brief Summary
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and...
Detailed Description
Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkos...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- HbA1c \> 7,5%
- Body Mass Index (BMI) ≥ 27,5 kg/m2
Exclusion
- acute infections
- severe diseased with hospital stay during the last 3 months
- chronic diseases
- chemotherapy or cortisone treatment
- weight loss of more than 2 kg per week during the last month
- smoking cessation during the last 3 months or planned
- weight-influencing medication
- pregnancy, breast-feeding or lack of contraception
- high-level physical activity of more than 1h per day
- incompatibility with components of the PRMR
- participation in an other study during the last 6 months
- For the open-label registry, the only inclusion criterium is type 2 diabetes.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02230501
Start Date
February 1 2011
End Date
December 31 2023
Last Update
January 23 2024
Active Locations (1)
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1
West German Centre of Diabetes and Health
Düsseldorf, Germany, 40591