Primary: To investigate the effect on leg muscle mass in the test group compared to the control group in older obese type 2 diabetes patients after 13 weeks of interventionSecondary: - To investigate the effect on glycemic control in the test group…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Leg muscle mass (from dual-energy x-ray absorptiometry [DXA]) [kg]
Secondary outcome
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]
Background summary
Diabetes type 2 is a chronic disease strongly related to aging and overweight.
Older obese diabetes patients have a decreased metabolic stability including a
disturbance of the glucose uptake and lipid metabolism. Besides, older people,
and especially older obese people with diabetes are very vulnerable for loss of
muscle mass. Muscle mass is important for physical functioning and mobility on
one hand. On the other hand, it is an important organ for energy and substrate
metabolism and therefore important for metabolic stability.
The incidence and burden of diabetes and obesity can be improved with a healthy
lifestyle. Decreasing overweight is therefore an important focus in the
standard diabetes care in order to handle or improve the diabetes. However,
weight loss is usually related to loss of muscle mass, which could deteriorate
metabolic stability and mobility on long term.
A recent study has shown that a newly developed nutritional supplement, high in
protein, causes preservation of muscle mass, compared to an iso-caloric control
product, in obese elderly on a hypo-caloric diet in combination with a training
program during a 13 week randomized trial.
The current study was set up to investigate whether a nutritional supplement
high in protein, compared to an iso-caloric control product, can have a
positive effect on the preservation of muscle mass and on glycemic control in
older overweight diabetes type 2 patients who are participating in a similar
weight loss program, consisting of a hypo-caloric diet and a training program
during 13 weeks.
The results of this clinical study may contribute to the development of a
weight loss program for older obese type 2 diabetes patients.
Study objective
Primary: To investigate the effect on leg muscle mass in the test group
compared to the control group in older obese type 2 diabetes patients after 13
weeks of intervention
Secondary:
- To investigate the effect on glycemic control in the test group compared to
the control group in older overweight/obese type 2 diabetes patients after 13
weeks of intervention
- To investigate the effect on body composition in the test group compared to
the control group in older obese type 2 diabetes patients after 13 weeks of
intervention
Study design
Exploratory; randomized; controlled; double-blind; parallel-group;
single-centre study
Intervention
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 after dissolving in
water.
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).
Study burden and risks
Subjects should abide to a hypocaloric diet and 3 times a week exercise under
supervision for 13 weeks. Besides, the following procedures will take place
during study visits (screening and V1-V4): measuring blood pressure and pulse
(2x), indirect calorimetry (2x), 3 day dietary- and activity diary (3x),
measuring ECG and blood pressure in rest and during exercise (1x), venepuncture
(2x), Oral Glucose Tolerance Test including 5 times blood sampling via cannula
(2x), bring first-morning urine sample (3x), finger pricks (1x required during
screening, 4x optional before and during OGTT), DXA scan (3x), anthropometrics
(5x), measurement of muscle power (3x), measurement of physical performance
(5x), BodPod (3x), BIA (3x), RAND and GI tolerance questionnaire (3x), RSE and
HAD questionnaires (2x), product intake (daily 1 or 2 servings, for 13 weeks)
and complete a product intake diary.
Subjects should arrive fasted at a study visit four times. In addition,
subjects should refrain from any sort of intensive physical activity for 48
hours prior to the 2 visits on which OGTT is performed, should not consume any
alcohol 24 hours prior to these visits, and should eat the same diner prior to
these visits. During study participation, use of protein- or amino acid
containing nutritional supplements is not permitted. In addition, subjects
should not donate blood during study participation.
Based on the available data from previous studies no specific adverse effects
are anticipated. However, complaints such as belching, feeling of fullness,
nausea, dry mouth and thirst may occur.
Due to the presence of high protein and the predisposition of patients with
type 2 Diabetes to renal diseases, patients are only eligible for study
participation if the estimated Glomerular Filtration Rate at screening is >=60
mL/min. Moreover, parameters to assess renal function are monitored throughout
the study.
Substituting the caloric value of proteins in the test product for
carbohydrates in the control product may result into a higher post prandial
glucose response after consumption of the control product. Therefore, the
carbohydrate composition of the control supplement is composed of a mix of fast
and predominantly slow release carbohydrate sources to alleviate the post
prandial glucose peak. In addition, both products are consumed in a caloric
restricted regime and simultaneous with an exercise program, which would be
expected to deliver benefits on blood glucose and lipid management.
Furthermore, the potential occurrence of hypo- or hyperglycemic symptoms will
be monitored throughout the study.
A light pain can be experienced during the placement of the cannula for blood
sampling. Sometimes a blue spot appears afterwards at the place of the cannula.
The amount of radiation that is experienced during the DXA scans (maximum 13,5
µSv per visit) is equal to one and a half to two times the average natural
background radiation at sea level during one day. The DXA scan could possibly
indicate signs of osteoporosis. When this is the case, subjects will be
informed accordingly.
A healthy diet and exercise are very important for diabetes type 2 patients.
During this study, subjects will receive intensive coaching in this. This could
have a positive effect on the subject*s health. Because nutritional supplements
are used in the study, no serious adverse events are expected. Subjects will be
carefully screened for eligibility and during the study subjects will receive
intensive coaching of dieticians (students) and adverse events and lab safety
values will be reviewed by a physician.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46790.056.14 |