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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593215
First Posted: May 8, 2012
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Anders Rosengren, MD PhD, Region Skane
  Purpose
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 Intervention Phase
Type 2 Diabetes Drug: Yohimbine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anders Rosengren, MD PhD, Region Skane:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 50
Study Start Date: May 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
Sweden
Skanes Universitetssjukhus
Malmo, Skane, Sweden, 20502
Sponsors and Collaborators
Anders Rosengren, MD PhD
Region Skane
Lund University
Investigators
Principal Investigator: Anders Rosengren, MD PhD Region Skane
  More Information

Responsible Party: Anders Rosengren, MD PhD, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01593215     History of Changes
Other Study ID Numbers: 2010-018604-85
First Submitted: May 3, 2012
First Posted: May 8, 2012
Results First Submitted: October 31, 2014
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:
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