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.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

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 > 53 mmol/mol (>7.0 %)
3. - BMI > 30 kg/m2 or
- BMI >27 kg/m2 in combination with a waist circumference > 88 cm for women and > 102 cm for men
4. Willingness that general practitioner will be notified on study participation
5. Written informed consent
6. Willingness and ability to comply with the protocol
7. Ability to comply with the exercise protocol as assessed by a sports physician.

Exclusion Criteria

1. Specific medical history: 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 physician.
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).
3. Wearing an electronic implant and /or pacemaker
4. Renal disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min as based on MDRD formula)
5. Hepatic disease (liver enzymes ALAT, ASAT, GGT or ALP greater than 3 times Upper Limit of Normal)
6. Use within 2 weeks prior to baseline and/or expected use during the study of:
- Corticosteroids for systemic use
- Antibiotics for systemic use
7. Use of insulin
8. Change in dose within three months prior to baseline of:
- Antidepressants
- Neuroleptics
- Lipid lowering medication
9. Specific dietary and/or lifestyle factors present within three months prior to baseline:
- Involuntary weight loss of at least 5%.
- Use of protein containing or amino acid containing nutritional supplements
10. Known allergy to cow*s milk and milk products or the ingredients of the study products
11. Known galactosaemia
12. Known lactose intolerance
13. More than 22 µg (880 IU) of daily Vitamin D intake from non-food sources (such as supplements and prescribed medication)
14. More than 500 mg of daily calcium intake from non-food sources (such as supplements and prescribed medication)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Leg muscle mass (from dual-energy x-ray absorptiometry [DXA]) [kg]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Glycemic control:<br /><br>- Oral-glucose-insulin sensitivity index (based on oral glucose tolerance test<br /><br>[OGTT])<br /><br>- HbA1c (mmol/mol)<br /><br>- Fasting plasma glucose (mmol/l)<br /><br>- 2h plasma glucose (mmol/l) (based on OGTT)<br /><br><br /><br>Body composition:<br /><br>- Appendicular skeletal muscle mass (from DXA) [kg]<br /><br>- Fat mass (from BodPod) [kg, %]<br /><br>- Body Weight [kg]</p><br>