NCT02230501

Metabolic Activation With Protein-rich Formula Diet

Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: West German Center of Diabetes and Health · Academic / Other
• Sex: All
• Age: 25 Years – 79 Years
• Healthy volunteers: Not accepted

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 weight in type 2 diabetes mellitus (T2DM) patients injecting \>100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin. A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.

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-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication. In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	stringent diet regimen
DIETARY_SUPPLEMENT	moderate diet regimen

Timeline

• Start date: 2011-02-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2014-09-03
• Last updated: 2024-01-23

Locations

1 site across 1 country: Germany