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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Leicester.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University Hospitals, Leicester
Royal College of Surgeons
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01515059
First received: January 18, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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 Intervention
Obesity
Device: FreeStyle Navigator

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • Glycaemic shift [ Time Frame: Baseline - 12 weeks post surgery ] [ Designated as safety issue: No ]
    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:
  • Change in number of hyperglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The time taken for a change in the number of hyperglycaemic events (≥ 10.0 mmol/l for a duration of ≥ 10 minutes) to

  • Change in duration of hyperglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The time taken for a change in the duration of hyperglycaemic events (minutes) to be observed

  • Change in number of hypoglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    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)

  • Change in duration of hypoglycaemic events [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The time taken for a change in the duration of hypoglycaemic event (minutes) to be observed

  • Change in GLP-1 Profile [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in the area under the curve of the GLP1 profile between visit 1 and 2

  • Change in GIP profile [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in the fasting levels GIP between visit 1-2 and 2-3

  • Change in insulin profile [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in the fasting levels of insulin between visit 1-2 and 2-3

  • Change in HbA1c [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in Hba1c between visit 1 and 3

  • Change in FPG [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in fasting glucose levels between visit 1 and 3

  • Change in 2h glucose [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in 2 hour post load glucose levels between visit 1 and 3

  • Change in MAGE [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in mean amplitude of glycaemic excursions (MAGE) between visit 1 and 3

  • Change in subjective appetite [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in subjective appetite between visit 1 - 3 and over the course of the hospital stay

  • Change in subjective palatability [ Time Frame: Baeline to 12 weeks post sugery ] [ Designated as safety issue: No ]
    The change in subjective palatability of meal test between visit 1 and 3

  • Change in appetite via VAS [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in appetite as measured via visual analogue scale between visits 1 and 3 and change throughout inpatient stay.

  • Change in palatability via VAS [ Time Frame: Baseline to 12 weeks post surgery ] [ Designated as safety issue: No ]
    The change in palatability as measured via visual analogue scale


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bariatric sugery patients
Obese patients who are awaiting either a gastric bypass or sleeve gastrectomy
Device: FreeStyle Navigator
The device is a continuous glucose monitoring unit (CGMS) that consists of a receiver, transmitter and sensor. It is used for continuous glucose monitoring before immediately after and 12 weeks following surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515059

Contacts
Contact: Emer Brady, PhD 01162584223 emer.brady@uhl-tr.nhs.uk
Contact: Benjamin Hunt, PhD 01162584223 benjamin.d.hunt@uhl-tr.nhs.uk

Locations
United Kingdom
Leicester Royal Informiary Not yet recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Emer Brady, PhD    01162584223    emer.brady@uhl-tr.nhs.uk   
Contact: Benjamin Hunt, PhD    01162584223    benjmain.d.dhunt@uhl-tr.nhs.uk   
Principal Investigator: Melanie Davies, MD         
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Royal College of Surgeons
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
Principal Investigator: Benjamin D Hunt, PhD University Hospitals, Leicester
  More Information

No publications provided

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01515059     History of Changes
Other Study ID Numbers: 11/EM/0463
Study First Received: January 18, 2012
Last Updated: January 20, 2012
Health Authority: United Kingdom: National Health Service

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014