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Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant (YOH1)

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ClinicalTrials.gov Identifier: NCT01593215
Recruitment Status : Completed
First Posted : May 8, 2012
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Anders Rosengren, MD PhD, Region Skane

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Yohimbine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant
Study Start Date : May 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Placebo first then yohimbine
placebo first, then yohimbine
 Drug: Yohimbine
Yohimbine capsule
Active Comparator: Yohimbine first then placebo
Yohimbine first then placebo
 Drug: Yohimbine
Yohimbine capsule


Outcome Measures
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Primary Outcome Measures :
  1. Insulin Secretion [ Time Frame: 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 Outcome Measures :
  1. Glucose [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593215


Locations
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Sweden
Skanes Universitetssjukhus
Malmo, Skane, Sweden, 20502
Sponsors and Collaborators
Anders Rosengren, MD PhD
Region Skane
Lund University
Investigators
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Principal Investigator: Anders Rosengren, MD PhD Region Skane
More Information
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Responsible Party: Anders Rosengren, MD PhD, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01593215    
Other Study ID Numbers: 2010-018604-85
First Posted: May 8, 2012    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Anders Rosengren, MD PhD, Region Skane:
genetics
type 2 diabetes
insulin secretion
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Yohimbine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents