The aim of this study is to investigate the glycemic effects of the consumption of soft drinks, under fully standardized nutritional conditions, in obese type 2 diabetes patients and non-obese and obese normoglycemic control subjects.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
glucose concentration
Secondary outcome
24h hyperglycemia.
Background summary
It is suggested that the consumption of food-stuffs which contain large amounts
of sugar increase the risk for the development obesity, insulin resistance and
type 2 diabetes through strong increases in postprandial blood glucose
concentrations. This assumption has lead to a boom in the sales of so-called
light products. However, the actual effect of sugar (sacharose) containing
foods-stuffs (e.g. soft drinks) on glycemic variation has not been investigated
under real-life conditions.
Study objective
The aim of this study is to investigate the glycemic effects of the consumption
of soft drinks, under fully standardized nutritional conditions, in obese type
2 diabetes patients and non-obese and obese normoglycemic control subjects.
Study design
Monitoring of the glucose homeostasis in type 2 diabetes patients and control
subjects during a period of 40 hours in which sugarcontaining beverages will be
compared with placebo beverages.
Intervention
consumption of sugar containing beverages
Study burden and risks
Screening:
1 x Oral Glucose Tolerance Test (OGTT) of 2 hours
1 x hydrostatic weighing method of 0,5 hour
Test:
The time investment for each subject will be ~80 hours, divided over 2, 2 day
periods with each test-day separated by at least 5 days. During these test-days
the subjects will remain at the university for approximately 1,5 hours. For the
remaining part of the tests the subjects can resume their normal daily
activities.
Placement of the venous catheter or the microdialysis fiber can lead to mild
discomfort comparable to a normal blood draw. A hematoma could appear on the
place of the venapunction or insertion of the microdialysis fiber.
The beverages will contain normal sugar which is a standard additive and is
part of the normal diet.
Canceling the diabetes medication for a period of two days results in an
increase in blood glucose concentrations but does not result in a serious
disturbance of the glucose homeostasis and blood glucose concentrations are
normalized within 1-2 days after the screening. After the screening the subject
can resume their normal medication routine.
postbus 616
6200 MD, Maastricht
Nederland
postbus 616
6200 MD, Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Lean NGT Group
· Male
· Age between 40 and 60 years
· Normoglycemic (according to 2006 ADA guidelines)
· BMI < 30 kg/m2;Obese NGT Group
· Male
· Age between 40 and 60 years
· Normoglycemic
· BMI 30- 35 kg/m2 ;Obese Type 2 Diabetes group
· Male
· Age between 40 and 60 years
· BMI 30- 35 kg/m2
· Oral blood glucose lowering medication
Exclusion criteria
· Exogenous insulin use
· Cardiac disease (any cardiac event in the last 5 years)
· HbA1c >10%
· Microalbuminuria: albumin:creatinine ratio >2,5
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 | NL16188.068.07 |