An intense nutritional training program for obese patients with type 2 diabetes mellitus: a randomised controlled two-year intervention study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30261920

Enrollment

160

Registered

2006-02-10

Start date

2002-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Intense nutritional training program versus usual care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus (the diagnosis must be made at least six months before inclusion in the study) 2. Body Mass Index (BMI) >27 3. Aged between 35 and 70 years 4. Medication with at least two anti-diabetic drugs and/or antihypertensive drugs and/or lipid-lowering drugs 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Creatinine >2.0 mg/dl 2. Transaminase (>3 times higher than normal) 3. Alcohol or drug abuse 4. Severe psychiatric disorders 5. Eating disorders

Design outcomes

Primary

Measure	Time frame
1. Costs for diabetes medication in Euro 2. Cost efficiency to achieve therapy objectives 3. Fasting blood sugar 80-120 mg/dl 4. HbA1c 45 mg/dl 8. Low density lipoprotein-cholesterol <115 mg/dl	—

Secondary

Measure	Time frame
1. Quality of life 2. Differences in compliance 3. Satisfaction with the respective therapy	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026