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Analysing Differences in Glycaemic Control Immediately Post Obesity SurgEry (The ADIPOSE Study) (ADIPOSE)

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ClinicalTrials.gov Identifier: NCT01515059
Recruitment Status : Terminated (Slow recruitment and sufficient data available to analyse)
First Posted : January 23, 2012
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

Study Description
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Brief Summary:

It is well established that bariatric (weightloss) surgery affords considerable improvement in glycaemic control (control of blood sugar), and in many cases may lead to a complete resolution of type 2 diabetes. However, the mechanisms underlying these changes are yet to be elucidated and no research project to date has attempted to characterise changes in glycaemic control sooner than 3 days post surgery.

The primary objective of this study is to characterise changes in glycaemic control in individuals immediately following such surgery for a period of five days. Participants will be fitted with a continuous blood glucose measurement system (CGMS) prior to leaving theatre, which electronically records their blood glucose concentration every minute for up to five days. Upon returning the device each participant will undergo a standard meal test and have a small blood sample taken at 30 minute intervals (0-120 minutes) for the quantification of incretins (gut hormones involved in medium term control of blood sugar) insulin, glucose and appetite hormones.

These measurements will be compared to those collected at the baseline session, three weeks prior to the patient's surgery. Additional baseline visit measurements include: fasting lipid profile, insulin concentration, blood glucose concentration, HBA1C (long term blood glucose measurement), blood pressure, height, weight, waist circumference, and an oral glucose tolerance test (OGTT) and medical and family history.

All patients will be followed up twelve weeks post surgery, during which, all baseline measurements will be repeated.


Condition or disease
Obesity

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Study Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Pilot Study Investigating the Effects of Bariatric Surgery on Measures of Glycaemic Control and Incretin Levels
Study Start Date : September 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015
Groups and Cohorts
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Group/Cohort
Bariatric sugery patients
Obese patients who are awaiting either a gastric bypass or sleeve gastrectomy


Outcome Measures
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Primary Outcome Measures :
  1. Glycaemic shift [ Time Frame: Baseline - 12 weeks post surgery ]
    The primary outcome is time taken for a glycaemic shift to be observed, as measured by CGMS. This is the mean proportion (%) of time spent either above (≥10mmol/l), below (≤3.1mmol/l) or within (3.2-9.9mmol/l) our predefined glycaemic ranges will be calculated for each participant over the recording period and adjusted for 24 hours. A glycaemic shift in this context is defined as a statistically (p<0.05) significant reduction or increase in the proportion of time spent within a glycaemic range i.e. shift from hyperglycaemic to normoglycaemic range.


Secondary Outcome Measures :
  1. Change in number of hyperglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ]
    The time taken for a change in the number of hyperglycaemic events (≥ 10.0 mmol/l for a duration of ≥ 10 minutes) to

  2. Change in duration of hyperglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ]
    The time taken for a change in the duration of hyperglycaemic events (minutes) to be observed

  3. Change in number of hypoglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ]
    The time taken for a change in the number of hypoglycaemic events (≤ 3.1 mmol/l for a duration of ≥ 10 minutes) to be observed (adjusted for 24 hours)

  4. Change in duration of hypoglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ]
    The time taken for a change in the duration of hypoglycaemic event (minutes) to be observed

  5. Change in GLP-1 Profile [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in the area under the curve of the GLP1 profile between visit 1 and 2

  6. Change in GIP profile [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in the fasting levels GIP between visit 1-2 and 2-3

  7. Change in insulin profile [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in the fasting levels of insulin between visit 1-2 and 2-3

  8. Change in HbA1c [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in Hba1c between visit 1 and 3

  9. Change in FPG [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in fasting glucose levels between visit 1 and 3

  10. Change in 2h glucose [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in 2 hour post load glucose levels between visit 1 and 3

  11. Change in MAGE [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in mean amplitude of glycaemic excursions (MAGE) between visit 1 and 3

  12. Change in subjective appetite [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in subjective appetite between visit 1 - 3 and over the course of the hospital stay

  13. Change in subjective palatability [ Time Frame: Baeline to 12 weeks post sugery ]
    The change in subjective palatability of meal test between visit 1 and 3

  14. Change in appetite via VAS [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in appetite as measured via visual analogue scale between visits 1 and 3 and change throughout inpatient stay.

  15. Change in palatability via VAS [ Time Frame: Baseline to 12 weeks post surgery ]
    The change in palatability as measured via visual analogue scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 successive obese patients who are awaiting either a gastric bypass or sleeve gastrectomy
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • No active psychotic illness
  • On the waiting list for bariatric surgery at the Leicester Royal Infirmary and thus meeting the local eligibility criteria for this procedure

Exclusion Criteria:

  • < 18 years of age
  • Pregnant
  • Active psychotic illness
  • Receiving either GLP1 analogue or DPPIV inhibitor therapy
  • History of dug or alcohol dependancy
  • History of poorly controlled/severe mental health problems
  • Presence of any comorbidities contraindicative of abdominal surgery or anaesthesia (American Society of Anaesthesiology grade 4, certain grade 3)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01515059


Locations
United Kingdom
Leicester Diabetes Centre
Leicester, Leicestershire, United Kingdom, LE5 4PW
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Investigators
Principal Investigator: Melanie Davies, MD University of Leicester
Principal Investigator: David Bowrey, MD Universty Hospitals of Leicester NHS Trust
Principal Investigator: Kamlesh Khunti, MD University of Leicester
Principal Investigator: Patrice Carter, PhD University of Leicester
Principal Investigator: Christopher Sutton, MD University Hospitals, Leicester
Principal Investigator: Laura Gray, PhD University of Leicester
Principal Investigator: Emer Brady, PhD University Hospitals, Leicester
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01515059     History of Changes
Other Study ID Numbers: 11/EM/0463
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by University of Leicester:
obesity
diabetes
bariatric surgery
gastric bypass
insulin
 glucose
incretins
leptin
ghrelin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs