GLUCOSURG1: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01257087
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Obesity	Drug: Insulin	N/A

Detailed Description

Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive glycaemic control Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Drug: Insulin; All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.; Other Names: Insulin Glargine
Active Comparator: Conservative glycaemic control Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Drug: Insulin; All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.; Other Names: Insulin Glargine

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6% [1 year after surgery]

   Patients will be tested off all anti-diabetes medications if safe to do so to assess the percentage of patients with Type 2 Diabetes Mellitus who achieve fasting blood glucose of less than 5.6 mmol/l and/or HbA1c of less than 6%

Secondary Outcome Measures

1. Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively [1 year after surgery]

   A list of patients medication will be collected to assess the percentage of Type 2 Diabetes Mellitus patients with a reduction in the doses/number of diabetes medications used preoperatively

2. Number of Participants With Microvascular Events [1 year after surgery]

   Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

• Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College Healthcare NHS Trust	London		United Kingdom	W6 8RF

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Carel W le Roux, MRCP, PhD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carel Le Roux, Consultant metabolic medicine, Imperial College London
• ClinicalTrials.gov Identifier: NCT01257087
• Other Study ID Numbers: GLUCOSURG1
• First Posted: Dec 9, 2010
• Last Update Posted: Nov 13, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Carel Le Roux, Consultant metabolic medicine, Imperial College London: Type 2 Diabetes Mellitus; Obesity; Bariatric Surgery; Glycaemic control; Microvascular complications; Intensive; Conservative
• Additional relevant MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc; Insulin Glargine

Study Results

Participant Flow

Arm/Group Title	Intensive Glycaemic Control	Conservative Glycaemic Control
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Period Title: Overall Study
STARTED	18	17
COMPLETED	18	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intensive Glycaemic Control	Conservative Glycaemic Control	Total
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Total of all reporting groups
Overall Participants	18	17	35
Age, Customized (years) [Mean (Standard Deviation) ]
Age	55 (6)	49 (7)	52 (6.5)
Sex/Gender, Customized (Count of Participants)
Male	5 27.8%	10 58.8%	15 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	18 100%	17 100%	35 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
HbA1C (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	8.7 (1.2)	8.8 (1.0)	8.75 (1.1)

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%
Description	Patients will be tested off all anti-diabetes medications if safe to do so to assess the percentage of patients with Type 2 Diabetes Mellitus who achieve fasting blood glucose of less than 5.6 mmol/l and/or HbA1c of less than 6%
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

not different

Arm/Group Title	Intensive Glycaemic Control	Conservative Glycaemic Control
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Measure Participants	18	17
Count of Participants [Participants]	4 22.2%	4 23.5%

2. Secondary Outcome

Title	Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively
Description	A list of patients medication will be collected to assess the percentage of Type 2 Diabetes Mellitus patients with a reduction in the doses/number of diabetes medications used preoperatively
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intensive Glycaemic Control	Conservative Glycaemic Control
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Measure Participants	18	17
Count of Participants [Participants]	18 100%	17 100%

3. Secondary Outcome

Title	Number of Participants With Microvascular Events
Description	Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intensive Glycaemic Control	Conservative Glycaemic Control
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.	Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Measure Participants	18	17
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Not different
Arm/Group Title	Intensive Glycaemic Control		Conservative Glycaemic Control
Arm/Group Description	Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.		Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
All Cause Mortality
	Intensive Glycaemic Control		Conservative Glycaemic Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Serious Adverse Events
	Intensive Glycaemic Control		Conservative Glycaemic Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Intensive Glycaemic Control		Conservative Glycaemic Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		1/17 (5.9%)
Gastrointestinal disorders
Abdominal pain	1/18 (5.6%)	1	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.