Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients – a 13-week randomised, controlled exploratory study with a 24-week follow-up period.
- Conditions
- Diabetes type 2, Obesity(in Dutch: Diabetes type 2, obesitas)
- Registration Number
- NL-OMON21917
- Lead Sponsor
- utricia Research BV
- Brief Summary
Effect of an Enriched Protein Drink on Muscle Mass and Glycemic Control during Combined Lifestyle Intervention in Older Adults with Obesity and Type 2 Diabetes: A Double-Blind RCT. https://doi.org/10.3390/nu13010064
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1.Age 55-85 years old, inclusive
2. Ambulant type 2 diabetes patients (verified by used medication for Diabetes). In the event no medication is used HbA1c should be ≥ 43mmol/mol (≥ 6.1%)
3.- BMI >30 kg/m2 or
1.Specific medical history: Instable Angina Pectoris, cardiac infarcts and/or cardiac surgery within 3 months prior to baseline, any malignant disease during the last five years except for adequately treated prostate cancer without evidence of metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ and non-melanoma skin cancer, and other relevant medical history that could affect the study outcome as judged by the study investigator.
2.Any gastrointestinal disease that interferes with bowel function and nutritional intake (e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eg muscle mass (from dual-energy x-ray absorptiometry [DXA]) [kg]
- Secondary Outcome Measures
Name Time Method Glycemic control: <br>-Oral-glucose-insulin sensitivity index (based on oral glucose tolerance test [OGTT])<br>-HbA1c (mmol/mol)<br>-Fasting plasma glucose (mmol/l)<br>-2h plasma glucose (mmol/l) (based on OGTT)<br><br>Body composition:<br>-Appendicular skeletal muscle mass (from DXA) [kg]<br>-Fat mass (from DXA) [kg]<br>-Body weight [kg]