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

January 18, 2012
January 20, 2012
March 2012
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01515059 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Analysing Differences in Glycaemic Control Immediately Post Obesity SurgEry (The ADIPOSE Study)
A Prospective Pilot Study Investigating the Effects of Bariatric Surgery on Measures of Glycaemic Control and Incretin Levels

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

20 successive obese patients who are awaiting either a gastric bypass or sleeve gastrectomy

Obesity
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.
Bariatric sugery patients
Obese patients who are awaiting either a gastric bypass or sleeve gastrectomy
Intervention: Device: FreeStyle Navigator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
July 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact: Emer Brady, PhD 01162584223 emer.brady@uhl-tr.nhs.uk
Contact: Benjamin Hunt, PhD 01162584223 benjamin.d.hunt@uhl-tr.nhs.uk
United Kingdom
 
NCT01515059
11/EM/0463
Not Provided
University of Leicester
University of Leicester
  • University Hospitals, Leicester
  • Royal College of Surgeons
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
University of Leicester
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP