Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo first then yohimbine

placebo first, then yohimbine

Group Type ACTIVE_COMPARATOR

Yohimbine

Intervention Type DRUG

Yohimbine capsule

Yohimbine first then placebo

Group Type ACTIVE_COMPARATOR

Yohimbine

Intervention Type DRUG

Yohimbine capsule

Interventions

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Yohimbine

Yohimbine capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No