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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.


- candidate number17264
- NTR NumberNTR4497
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2014
- Secondary IDsTif.2.C/A/0 / Nutricia Research 
- Public TitleProtein 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.
- Scientific TitleProtein 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.
- ACRONYMProbe
- hypothesisH0: The effect of using test intervention is equal to the effect of the control intervention with respect to change in leg muscle mass in obese older adult patients with type 2 Diabetes after 13 weeks of intervention H1: The effect of using test intervention is unequal to the effect of the control intervention with respect to change in leg muscle mass in obese older adult patients with type 2 Diabetes after 13 weeks of intervention
- Healt Condition(s) or Problem(s) studiedObesity, Diabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. 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 criteria1. 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 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)
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 cows milk and milk products or the ingredients of the study products
11. Known galactosaemia
12. Known lactose intolerance
13. More than 22g (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)
15. Current alcohol or drug abuse in opinion of the investigator
16. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
17. Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to baseline
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate31-jul-2017
- Target number of participants120
- InterventionsDuration of intervention: 13 weeks Intervention group: A high protein oral nutritional supplement (ONS) Control group: An iso-caloric control drink with similar taste and appearance Both study products will be compared as part of a weight loss program consisting of a calorie restriction diet and a resistance type exercise protocol. In this study protocol will therefore be referred to the comparison of the test group (weight loss program including use of test product) versus the control group (weight loss program including use of control product).
- Primary outcomeLeg muscle mass (from dual-energy x-ray absorptiometry [DXA]) [kg]
- Secondary outcomeGlycemic 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]
- TimepointsTime points primary and secondary parameters: V1 (week 0) and V3 (week 13)
- Trial web siten/a
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R. Memelink
- CONTACT for SCIENTIFIC QUERIES Johan Vogel, de
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Hogeschool van Amsterdam/Amsterdam University of Applied Sciences, Nutricia Research - Centre for Specialised Nutrition
- Publications
- Brief summaryThis 13-week randomised, double blind, controlled study is designed to evaluate whether a high protein ONS, compared to an iso-caloric control product, would offer benefits on skeletal muscle mass preservation and glycemic control in older obese diabetes type 2 patients who participate in a weight loss program, consisting of a calorie restriction diet and predominantly resistance exercise. The results of this clinical study may contribute to the development of a weight loss program for the obese older adult diabetes type 2 patient.
- Main changes (audit trail)15-02-2015 inclusie en exclusie criteria aanpassing: Inclusie Criteria: 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%) 5. For patients who use SU-derivatives: a) Agreement of patient that his/her diabetes medication may be adapted b) Agreement of the treating physician to possible adjustment(s) of SU-derivative dose at the start and during the study, either by the study physician or by the treating physician based on advice of the study physician. Exclusie Criteria: 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.

19-feb-2017: NEW
Secondary Outcome: Fat mass (from DXA) [kg] (ipv Fat mass (from BodPod) [kg, %])
- RECORD8-apr-2014 - 19-feb-2017


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