Clinical trial NCT02230501: Metabolic Activation With Protein-rich Formula Diet
Official title: Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Almased Wellness GmbH
First posted: 2014-09-03
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the second part of the study, i.e. the open-label registry, there ist no randomization.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 1 year
measure: body weight
timeFrame: 12 weeks and 1 year
measure: blood pressure
timeFrame: 12 weeks and 1 year
measure: cholesterol
timeFrame: 12 weeks and 1 year
measure: fasting blood glucose
timeFrame: 12 weeks and 1 year
measure: quality of life
timeFrame: 12 weeks and 1 year
measure: nutrition
timeFrame: 12 weeks and 1 year
measure: physical activity
timeFrame: 12 weeks and 1 year
measure: antidiabetic medication
timeFrame: 12 weeks and 1 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Centre of Diabetes and Health
Study officials:
References: