Treatment of overweight persons with insulinresistance with a low dose metformin added to yoghurt. The early reduction of glucose, especially the postprandial glucose will hopefully slow the process from insuline resistance to diabetes mellitus.…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 HbA1c
Secondary outcome
1 weight
2 bloodpressure
3 taste of the product
4 metformin serumlevels
5 Insulinresistence by Homa glucose /insulin ratio
6 lipids
7 compliance
Background summary
Biguaniden
Biguaniden are medicines, which make cells more sensitive to insulin, so they
are used by patients with an insulinresistance like type 2 diabetes mellius in
overweight patients.The biguaniden (e.g.. metfomin ) also reduces the glucose
production in the liver. The active substance in metformin is metformine
.Metformin 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 metformin is 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 metfomin for a patient with diabetes mellitus is 2000mg a day
with a clear dose relationship efficacy: above the 2000mg metformin loses its
efficacy and we see more side effects. A serious side effect of metformin is
lactic acidosis which is related to the dose of metformine, alcohol use and
renal impairment. In the past, studies have been done with patients with an
increased risk of diabetes mellitus to treat them pre-emptive with metformin.
This treatment resulted in two studies in a risk reduction of 30% of developing
diabetes melitus.The idea of adding a low dose of metformine to 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
metformin added to yoghurt. The early reduction of glucose, especially the
postprandial glucose will hopefully slow the process from insuline resistance
to diabetes mellitus. 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 and metformin ( variable dosis of 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 finger bloodglucose will be taken on
day 21.
Intervention
Influence of metformin added to yoghurt on metabole control
Study burden and risks
During 6 weeks yoghurt with a low dose metformin 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 taste 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 and woman> 82 cm
Exclusion criteria
known with diabetes, hypertension or RR>150-90 mmHg,dyslipedemia 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 | NL36086.044.11 |