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.

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. - PROBE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40400

Enrollment

120

Registered

2014-06-23

Start date

2014-09-10

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Diabetes Mellitus type II

Interventions

Test product: A high protein oral nutritional supplement (ONS) Control product: An iso-caloric control drink with similar taste and appearance. Both products are in powder format and will be consumed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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]

Design outcomes

Primary

Measure	Time frame
Leg muscle mass (from dual-energy x-ray absorptiometry [DXA]) [kg]	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)