Metabolic Activation With Protein-rich Formula Diet

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: moderate diet regimen; Dietary Supplement: stringent diet regimen

• Registration Number: NCT02230501
• Lead Sponsor: West German Center of Diabetes and Health

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 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate diet regimen	moderate diet regimen	Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.
stringent diet regimen	stringent diet regimen	Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	change in hemoglobin A1c

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West German Centre of Diabetes and Health; 🇩🇪 Düsseldorf, Germany