Analysing Differences in Glycaemic Control Immediately Post Obesity SurgEry (The ADIPOSE Study)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2012 by University of Leicester
Sponsor:
University of Leicester
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01515059
First received: January 18, 2012
Last updated: November 12, 2014
Last verified: January 2012
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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 |
|---|
|
Obesity |
| 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: | November 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Bariatric sugery patients
Obese patients who are awaiting either a gastric bypass or sleeve gastrectomy
|
Show Detailed Description
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515059
Contacts
| Contact: Emer Brady, PhD | 01162584223 | emer.brady@uhl-tr.nhs.uk | |
| Contact: Patrice Carter, PhD | 01162584323 | pc154@le.ac.uk |
Locations
| United Kingdom | |
| Leicester Diabetes Centre | Recruiting |
| Leicester, Leicestershire, United Kingdom, LE5 4PW | |
| Contact: Emer Brady, PhD 01162588959 emer.brady@uhl-tr.nhs.uk | |
| Contact: Patrice Carter, PhD 01162584323 pc154@le.ac.uk | |
| Principal Investigator: Melanie Davies, MD | |
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
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: | November 12, 2014 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Leicester:
|
obesity diabetes bariatric surgery gastric bypass insulin |
glucose incretins leptin ghrelin |
ClinicalTrials.gov processed this record on March 02, 2015