To investigate the effect of oral magnesium supplementation on insulin sensitivity in people with T2DM and a low serum magnesium concentration.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in insulin sensitivity after oral
magnesium supplementation measured by the mean glucose infusion rate during the
last 30 minutes of the hyperinsulinemic euglycemic glucose clamp.
Secondary outcome
Secondary endpoints include the effect of oral magnesium supplementation on
HbA1c, insulin dose requirements, symptoms associated with hypomagnesemia,
blood pressure, physical activity and glucose-, lipid and inflammatory profile.
Additionally, we will explore the differences in glycemic control, lipid
profile and blood pressure between people with T2DM and normo- versus
hypomagnesemia.
Background summary
Hypomagnesemia is common in people with type 2 diabetes mellitus (T2DM).
Because of its association with insulin resistance, hypomagnesemia has been
suggested to play a role in the pathogenesis of T2DM. It is unknown whether
magnesium supplementation improves insulin resistance in people with
insulin-requiring T2DM and hypomagnesemia.
Study objective
To investigate the effect of oral magnesium supplementation on insulin
sensitivity in people with T2DM and a low serum magnesium concentration.
Study design
Placebo controlled, double blinded, randomized controlled, cross-over
intervention trial.
Intervention
Participants will receive placebo or magnesium gluconate drink 50 ml three
times a day (i.e. total daily magnesium dose of 15 mmol) for six weeks in a
randomized cross-over design. After both treatment periods, the participants
will undergo a hyperinsulinemic euglycemic glucose clamp.
Study burden and risks
The study participants will not benefit directly from participating in this
clinical trial, although theoretically, low magnesium levels are associated
with symptoms such as muscle cramps which may decrease during this trial.
Magnesium gluconate has a safe profile. Possible side effects of magnesium
gluconate are (temporary) gastro-intestinal symptoms like diarrhoea. The use of
venous catheters may cause hematomas or phlebitis which are self-limiting.
During the clamp there is a potential risk of developing hypoglycemia, yet this
risk is very low because plasma glucose levels are frequently monitored and
glucose 20% is continuously infused, the rate of which will be increased when
glucose levels tend to fall. In over 1000 clamps performed to date, severe
hypoglycemia has never occurred.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
* Clinical diagnosis of type 2 diabetes mellitus
* Treatment with insulin for at least one year
* Minimum age of 18 years
* Ability to provide informed consent
Exclusion criteria
* Treatment with more than 7.5 mg prednisone daily (or a comparable dose of
other oral corticosteroids)
* Use of magnesium supplementation in the week before screening
* Any cardiovascular event in the six months before screening
* Illnesses and unstable diseases that interfere with the primary outcome
* Chronic diarrhea
* Alcohol consumption of more than 14 units weekly
* MDRD-GFR < 45 ml/min/1.73m2
* Body-Mass Index < 18 or > 40 kg/m2
* Pregnancy or the wish to become pregnant
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-001243-27-NL |
| CCMO | NL77108.091.21 |