Metabolic Activation With Protein-rich Formula Diet

Type 2 Diabetes Mellitus Clinical Trial

— AVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230501
• Other study ID #: AVS
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 79 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• HbA1c > 7,5%

• Body Mass Index (BMI) = 27,5 kg/m2

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• stringent diet regimen

• moderate diet regimen

Locations

Country	Name	City	State
Germany	West German Centre of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Almased Wellness GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	change in hemoglobin A1c	12 weeks
Secondary	HbA1c	change in hemoglobin A1c	1 year
Secondary	body weight	change in body weight	12 weeks and 1 year
Secondary	blood pressure	change in systolic and diastolic blood pressure	12 weeks and 1 year
Secondary	cholesterol	change in total cholesterol change in HDL cholesterol change in LDL cholesterol	12 weeks and 1 year
Secondary	fasting blood glucose	change in fastin g blood glucose	12 weeks and 1 year
Secondary	quality of life	change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale)	12 weeks and 1 year
Secondary	nutrition	change in FEV (questionnaire for eating manners)	12 weeks and 1 year
Secondary	physical activity	change in physical activity questionnaire	12 weeks and 1 year
Secondary	antidiabetic medication	absolute amount of antidiabetic medication; increase or reduction	12 weeks and 1 year