treatment of overweight persons with insulinresistance with a low dose metformine add to yoghurt The early reduce of glucose especially the postprandial will hopefully decrease this process. This reduce of the glucose only needs to be 1 mmol and we…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 glucose and HbA1c
Secondary outcome
1 weight
2 bloodpressure
3 taste of the product
4 metformin serumlevels
5 Insulinresistence by Homa glucose /insulin ratio
6lipids
7compliance
Background summary
Biguaniden
Biguaniden are medicine which make cells more sensitive to insulin so they are
used by patients with an insulinresistance like type diabetes meelius with
overweight .The biguaniden (o.a. Metfomine ) also reduces the glucose
production in the liver.The active substance in metformine is metformine
.Metformine is since 1959 international available and works within1-3 hours.The
total effect can be up to 5 to 6 hours.
Symptomatic complaints as polydipsie disappear after a few days it slows both
the basal and post-prandial blood glucose levels.
Up till now metformine are only taken by patients with diabetes mellitus to
treat the metabolic syndrome and it also has a positive influence on the lipid
spectrum and blood pressure. We even see a slight weight loss.
The effective dose of metfomine for a patient with diabetes mellitus is 2000mg
a day with a clear dose relationship efficacy
Above the 2000mg metformine looses its efficacy and we see more side effects.
A serious side effect of metformine is lactaatacidose witch is related to the
dose of metformine, alcohol use and renal imparment. In the past, studies have
been done with patients with an increased risk of diabetes mellitus to treat
them pre-emptive with metformine. This treatment resulted in two studies to a
risk reduction of 30% of developing diabetes melitus.The idea of adding a low
dose of metformine to a nutrition for people with a high risk to develop a
heart disease and or diabetes mellitus has never been done till now.
Study objective
treatment of overweight persons with insulinresistance with a low dose
metformine add to yoghurt
The early reduce of glucose especially the postprandial will hopefully
decrease this process. This reduce of the glucose only needs to be 1 mmol and
we will see a reduce of 0,3-0,5% of the HbA1c. which can delay the devellopment
of diabetes mellitus type 2
Study design
A yoghurt containing metformin( variabel dosis ,250mg and 450 mg ) will be
giving during 6 weeks to persons with overweight ,body mass index more than 26
,before administration of the first dosage ,waist-side ,bodyweight
,bloodpressure are determined ,bloodsamples are taken before consumption on day
-14 ,day 0 start of the yoghurt consumption durung 6 weeks, day 42 bloodglucose
,HbA1c ,lipids and metformine levels are determined a vinger bloodglucose will
be taken on day 21
Intervention
influence of metformine admitted to yoghurt on metabole control
Study burden and risks
during 6 weeks yoghurt with a low dose metformine will be taken bij healthy
overweight persons ,3 times bloodsamples will be taken and once glucose in the
finger will be taken ,a diary for tast of the yoghurt must be filled in daily
middelstebaan7
5263ev
NL
middelstebaan7
5263ev
NL
Listed location countries
Age
Inclusion criteria
overweight BMI>26
Age>18 and <70
waist: man >92 cm en woman> 82 cm
Exclusion criteria
known with diabetes ,hypertension or RR>150-90 mmHG,dyslipedemie inherrited or cholesterol >6.5 mmol/l,alcoholcomsumption above 20 units a week ,serumcreatinine man >135umol/l and woman >110umol/l
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| Other | aangevraagd |
| EudraCT | EUCTR2010-019081-93-NL |
| CCMO | NL31713.044.10 |