Type 2 Diabetes
Conditions
Keywords
genetics, type 2 diabetes, insulin secretion
Brief summary
The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.
Detailed description
We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.
Interventions
DRUGYohimbine
Yohimbine capsule
Sponsors
Region Skane
Lund University
Anders Rosengren, MD PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * informed consent * age 18-70, for females only postmenopausal
Exclusion criteria
* heart disease * anxiety disorder * antidiabetic treatment other than metformin * adrenergic blockers * ulcus * allergy to any component in the capsules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion | 30 minutes after oral glucose | insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | 30 minutes after oral glucose | Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo First Then Yohimbine placebo first
Yohimbine: Yohimbine capsule | 25 |
| Yohimbine First Then Yohimbine Yohimbine first and then placebo | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo First Then Yohimbine | Yohimbine First Then Yohimbine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 7 | 60 years STANDARD_DEVIATION 8 |
| Region of Enrollment Sweden | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 6 / 49 |
| serious Total, serious adverse events | 0 / 49 | 1 / 49 |
Outcome results
Primary
Insulin Secretion
insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.
Time frame: 30 minutes after oral glucose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Insulin Secretion | 5 % increase of Ins30 |
| Yohimbine | Insulin Secretion | 29 % increase of Ins30 |
Secondary
Glucose
Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.
Time frame: 30 minutes after oral glucose